| Company | Device | Category | Pathway | Decision | FDA ID | Decision Date | Review | Archived |
|---|---|---|---|---|---|---|---|---|
H Honeynaps Co., Ltd. |
Somnum (Somnum) | Neurology | 510(k) | Cleared | K253390 | Jun 27, 2026 | 270d | Oct 26, 2026 |
I Imagine Milling Technologies, LLC |
Mist Ic | Dental | 510(k) | Cleared | K261122 | Jun 27, 2026 | 85d | Oct 26, 2026 |
T Time IS Brain, S.L. |
BraiN20® (BraiN20) | Neurology | 510(k) | Cleared | K253301 | Jun 27, 2026 | 271d | Oct 26, 2026 |
A Abbott Point of Care, Inc. |
i-STAT Crea cartridge with the i-STAT 1 System | Diagnostics | 510(k) | Cleared | K261039 | Jun 26, 2026 | 88d | Oct 26, 2026 |
T Therapixel |
MammoScreen® (5) | Imaging | 510(k) | Cleared | K260714 | Jun 26, 2026 | 113d | Oct 26, 2026 |
E Edwards Lifesciences |
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135) … | Surgical | 510(k) | Cleared | K254232 | Jun 26, 2026 | 179d | Oct 26, 2026 |
B BioHorizons Implant Systems, Inc. |
BioHorizons CEREC Compatible Ti-Bases | Dental | 510(k) | Cleared | K260061 | Jun 26, 2026 | 169d | Oct 26, 2026 |
S Shenzhen Changkun Technology Co., Ltd. |
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Women's Health | 510(k) | Cleared | K250070 | Jun 26, 2026 | 532d | Oct 26, 2026 |
E ElectroWire Medical |
LightningWire Transseptal Puncture System (TPS) | Cardiovascular | 510(k) | Cleared | K261745 | Jun 26, 2026 | 30d | Oct 26, 2026 |
P Phast Corp. |
PhAST instrument and PhAST Blood Culture Gram-negative Panel | Diagnostics | 510(k) | Cleared | K253316 | Jun 26, 2026 | 269d | Oct 26, 2026 |
S Shenzhen Dongdixin Technology Co., Ltd. |
TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Neurology | 510(k) | Cleared | K260412 | Jun 26, 2026 | 137d | Oct 26, 2026 |
B Bonebridge AG |
SALGINA 2.5mm Distal Radius System | Orthopedic | 510(k) | Cleared | K261351 | Jun 26, 2026 | 63d | Oct 26, 2026 |
Z Ziree Co., Ltd. |
Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1 … | Physical Medicine | 510(k) | Cleared | K261253 | Jun 26, 2026 | 71d | Oct 26, 2026 |
B Biotracker, LLC |
BioTracker 2.0 | Other | 510(k) | Cleared | K253306 | Jun 26, 2026 | 270d | Oct 26, 2026 |
S Spectrum Vascular |
Arterial Pressure Monitoring Set/Tray | Cardiovascular | 510(k) | Cleared | K261455 | Jun 26, 2026 | 56d | Oct 26, 2026 |
C Cadwell Industries, Inc. |
Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Neurology | 510(k) | Cleared | K261442 | Jun 26, 2026 | 57d | Oct 26, 2026 |
S Silony Medical GmbH |
VERTICALE® Navigation Instruments | Neurology | 510(k) | Cleared | K253921 | Jun 26, 2026 | 200d | Oct 26, 2026 |
A Arthrex, Inc. |
Arthrex FiberButton | Orthopedic | 510(k) | Cleared | K260018 | Jun 26, 2026 | 172d | Oct 26, 2026 |
R Rxsight, Inc. |
RxSight Light Adjustable Lens; Light Delivery Device | Ophthalmic | PMA Supplement | Approved | P160055/S054 | Jun 26, 2026 | 269d | Oct 26, 2026 |
M Merz North America, Inc. |
COAPTITE® Agent, Bulking, Injectable For Gastro-Urology Use | Other | PMA Supplement | Approved (30-day notice) | P040047/S083 | Jun 26, 2026 | 29d | Oct 26, 2026 |
A Abbott Medical |
Durata Leads; Optisure Leads; UltiSync Leads | Cardiovascular | PMA Supplement | Approved (30-day notice) | P950022/S154 | Jun 26, 2026 | 28d | Oct 26, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved (30-day notice) | P050037/S154 | Jun 26, 2026 | 29d | Oct 26, 2026 |
A Abbott Medical |
IsoFlex Leads | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960030/S085 | Jun 26, 2026 | 28d | Oct 26, 2026 |
A Abbott Medical |
Tendril STS Leads; Ultipace Leads; Optisense Leads | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960013/S134 | Jun 26, 2026 | 28d | Oct 26, 2026 |
S Stryker Neurovascular |
Surpass Evolve; Surpass Elite FDS | Neurology | PMA Supplement | Approved (30-day notice) | P170024/S026 | Jun 26, 2026 | 29d | Oct 26, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved (30-day notice) | P050052/S179 | Jun 26, 2026 | 29d | Oct 26, 2026 |
M Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) … | Neurology | PMA Supplement | Approved (30-day notice) | P100018/S054 | Jun 26, 2026 | 29d | Oct 26, 2026 |
F Farapulse, Inc. |
FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230030/S023 | Jun 26, 2026 | 9d | Oct 26, 2026 |
A Artivion, Inc. |
AMDS Hybrid Prosthesis | Cardiovascular | PMA | Approved | P250055 | Jun 26, 2026 | 179d | Oct 26, 2026 |
I Illumina, Inc. |
TruSight Oncology Comprehensive | Diagnostics | PMA Supplement | Approved | P230011/S002 | Jun 26, 2026 | 512d | Oct 26, 2026 |
S Siemens Medical Solutions USA, Inc. |
syngo.CT Coronary Cockpit | Imaging | 510(k) | Cleared | K253786 | Jun 25, 2026 | 211d | Oct 26, 2026 |
N Neuralytix |
iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Other | 510(k) | Cleared | K260992 | Jun 25, 2026 | 91d | Oct 26, 2026 |
D DePuy Ireland UC |
ATTUNE Total Knee System; ATTUNE Cementless Knee System | Orthopedic | 510(k) | Cleared | K261458 | Jun 25, 2026 | 55d | Oct 26, 2026 |
E ETHICON, Inc. |
Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | Surgical | 510(k) | Cleared | K253394 | Jun 25, 2026 | 268d | Oct 26, 2026 |
P Pendracare |
SimplGuide | Cardiovascular | 510(k) | Cleared | K261242 | Jun 25, 2026 | 71d | Oct 26, 2026 |
L Longeviti Neuro Solutions |
ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752) … | Neurology | 510(k) | Cleared | K260709 | Jun 25, 2026 | 113d | Oct 26, 2026 |
A Alphatec Spine, Inc. |
IntraOp Alignment System; CONTOUR3D Bending System | Orthopedic | 510(k) | Cleared | K253216 | Jun 25, 2026 | 269d | Oct 26, 2026 |
A ASESSO HEALTH, Inc. |
G-Series Grind Guard | Other | 510(k) | Cleared | K260790 | Jun 25, 2026 | 106d | Oct 26, 2026 |
A Apryse Software Corp |
MiPACS V5 (1.0.0) | Imaging | 510(k) | Cleared | K260231 | Jun 25, 2026 | 150d | Oct 26, 2026 |
P Phadia AB |
EliA CTD 13 Screen | Diagnostics | 510(k) | Cleared | K253367 | Jun 25, 2026 | 268d | Oct 26, 2026 |
S Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Anesthesiology | 510(k) | Cleared | K253330 | Jun 25, 2026 | 268d | Oct 26, 2026 |
V Vistar Medical Supplies Co., Ltd. |
DVT Garment | Cardiovascular | 510(k) | Cleared | K253386 | Jun 25, 2026 | 268d | Oct 26, 2026 |
G GN Hearing A/S |
Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | Other | 510(k) | Cleared | K254108 | Jun 25, 2026 | 188d | Oct 26, 2026 |
S Shenzhen Qinyi Electronic Technology Co., Ltd. |
Wearable breast pump (QY-101, QY-102, QY-108) | Women's Health | 510(k) | Cleared | K261025 | Jun 25, 2026 | 87d | Oct 26, 2026 |
I Intelligent Dots, LLC |
BedDot (G1) | Anesthesiology | 510(k) | Cleared | K253274 | Jun 25, 2026 | 269d | Oct 26, 2026 |
D Depuy Ireland UC |
VELYS Robotic-Assisted Solution | Neurology | 510(k) | Cleared | K260480 | Jun 25, 2026 | 132d | Oct 26, 2026 |
S Seers Technology Co., Ltd. |
mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Cardiovascular | 510(k) | Cleared | K253384 | Jun 25, 2026 | 268d | Oct 26, 2026 |
A Arthrex, Inc. |
Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Orthopedic | 510(k) | Cleared | K260809 | Jun 25, 2026 | 105d | Oct 26, 2026 |
U Uniqa Dental, Ltd. |
UNIQA® Dental Implants System | Dental | 510(k) | Cleared | K251188 | Jun 25, 2026 | 434d | Oct 26, 2026 |
W Weyo Surgical Technology , Ltd. |
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Women's Health | 510(k) | Cleared | K252584 | Jun 25, 2026 | 314d | Oct 26, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava Quad CRT-D DTBC1Q1 … | Cardiovascular | PMA Supplement | Approved | P010031/S922 | Jun 25, 2026 | 87d | Oct 26, 2026 |
E ETHICON, Inc. |
GYNECARE INTERCEED Absorbable Adhesion Barrier | Women's Health | PMA Supplement | Approved (30-day notice) | P880047/S070 | Jun 25, 2026 | 22d | Oct 26, 2026 |
D Defibtech, LLC |
Defibtech Automated External Defibrillator (AED) Systems | Cardiovascular | PMA Supplement | Approved | P160032/S016 | Jun 25, 2026 | 9d | Oct 26, 2026 |
E ETHICON, Inc. |
SURGICEL® Absorbable Hemostats | Surgical | PMA Supplement | Approved (30-day notice) | N12159/S130 | Jun 25, 2026 | 22d | Oct 26, 2026 |
E ETHICON, Inc. |
ETHIZIA Hemostatic Patch | Surgical | PMA Supplement | Approved | P240035/S002 | Jun 25, 2026 | 178d | Oct 26, 2026 |
P Physio-Control, Inc. |
LIFEPAK® 15 monitor/defibrillator | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160026/S068 | Jun 25, 2026 | 23d | Oct 26, 2026 |
A Abbott Medical |
MitraClip Systems | Cardiovascular | PMA Supplement | Approved (30-day notice) | P100009/S086 | Jun 25, 2026 | 27d | Oct 26, 2026 |
M Medtronic, Inc. |
Aurora EV ICD DVEA3E4 | Cardiovascular | PMA Supplement | Approved | P220012/S069 | Jun 25, 2026 | 87d | Oct 26, 2026 |
M Merz North America, Inc. |
Belotero Volume (+) Lidocaine Dermal Filler | Surgical | PMA Supplement | Approved (30-day notice) | P250020/S002 | Jun 25, 2026 | 30d | Oct 26, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR … | Cardiovascular | PMA Supplement | Approved | P980016/S955 | Jun 25, 2026 | 87d | Oct 26, 2026 |
A Abbott Medical |
TriClip Systems | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230007/S023 | Jun 25, 2026 | 27d | Oct 26, 2026 |
S Sw Technologies, Inc. |
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs … | General Hospital | 510(k) | Cleared | K252117 | Jun 24, 2026 | 352d | Oct 26, 2026 |
G Ge Medical Systems, LLC |
Enhanced Boundary for PCCT | Imaging | 510(k) | Cleared | K253560 | Jun 24, 2026 | 219d | Oct 26, 2026 |
H Hangzhou AGS MedTech Co., Ltd. |
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 … | Other | 510(k) | Cleared | K253393 | Jun 24, 2026 | 267d | Oct 26, 2026 |
S Stryker Neurovscular |
Target Xtra Detachable Coil | Neurology | 510(k) | Cleared | K261772 | Jun 24, 2026 | 26d | Oct 26, 2026 |
H Hangzhou Jimushi Meditech Co., Ltd. |
Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | Other | 510(k) | Cleared | K260394 | Jun 24, 2026 | 138d | Oct 26, 2026 |
S Shanghai Waylong Intelligent Technology Co.,Ltd |
Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Physical Medicine | 510(k) | Cleared | K260937 | Jun 24, 2026 | 96d | Oct 26, 2026 |
O Olympus Medical Systems Corporation |
HD Camera Head OLYMPUS CH-S200-08-LB | Other | 510(k) | Cleared | K261260 | Jun 24, 2026 | 69d | Oct 26, 2026 |
C Ceribell, Inc. |
Ceribell Neurology Review Software | Neurology | 510(k) | Cleared | K260998 | Jun 24, 2026 | 90d | Oct 26, 2026 |
M Medtronic, Inc. |
Concerto Versa Detachable Coil | Cardiovascular | 510(k) | Cleared | K261866 | Jun 24, 2026 | 20d | Oct 26, 2026 |
S Sonoma Pharmaceuticals, Inc. |
Microdacyn Wound Irrigation Solution | Other | 510(k) | Cleared | K261023 | Jun 24, 2026 | 86d | Oct 26, 2026 |
A Aroa Biosurgery , Ltd. |
Endoform Dermal Template | Other | 510(k) | Cleared | K260669 | Jun 24, 2026 | 114d | Oct 26, 2026 |
C Convatec Limited, Gdc Building |
ConvaVAC Negative Pressure Wound Therapy System | Surgical | 510(k) | Cleared | K253263 | Jun 24, 2026 | 268d | Oct 26, 2026 |
I Insera Therapeutics, Inc. |
CLEAR Aspiration System | Other | 510(k) | Cleared | K253404 | Jun 24, 2026 | 267d | Oct 26, 2026 |
S Silverceuticals, Inc. |
SilverCeuticals® Antimicrobial Wound Gel | Other | 510(k) | Cleared | K251929 | Jun 24, 2026 | 366d | Oct 26, 2026 |
S STERIS Corporation |
AMSCO 700 Steam Sterilizer | General Hospital | 510(k) | Cleared | K261055 | Jun 24, 2026 | 85d | Oct 26, 2026 |
M Medtronic, Inc. |
CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P930039/S278 | Jun 24, 2026 | 28d | Oct 26, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P830061/S236 | Jun 24, 2026 | 28d | Oct 26, 2026 |
S Shockwave Medical, Inc. |
Shockwave lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL … | Cardiovascular | PMA Supplement | Approved | P200039/S021 | Jun 24, 2026 | 77d | Oct 26, 2026 |
M Medtronic, Inc. |
Sprint Quattro Lead (6946M) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P920015/S306 | Jun 24, 2026 | 28d | Oct 26, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
SelectSecure Lead (3830) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P030036/S160 | Jun 24, 2026 | 28d | Oct 26, 2026 |
B Biotronik, Inc. |
Acticor 7 VR-T DX (429525); Acticor 7 VR-T DF4 ProMRI (429526); Rivacor 3 VR-T DF4 ProMRI (429574) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P050023/S212 | Jun 24, 2026 | 28d | Oct 26, 2026 |
K Keri Medical SA |
TOUCH® CMC 1 Prosthesis | Orthopedic | PMA Supplement | Approved (30-day notice) | P240020/S006 | Jun 24, 2026 | 22d | Oct 26, 2026 |
B Biotronik, Inc. |
Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P000009/S131 | Jun 24, 2026 | 28d | Oct 26, 2026 |
D DiaSorin, Inc. |
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus | Diagnostics | PMA Supplement | Approved (30-day notice) | P220034/S011 | Jun 24, 2026 | 20d | Oct 26, 2026 |
B Biotronik, Inc. |
Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P980023/S147 | Jun 24, 2026 | 28d | Oct 26, 2026 |
M Medtronic, Inc. |
Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P080006/S193 | Jun 24, 2026 | 28d | Oct 26, 2026 |
V Vascutek, Ltd. |
Thoraflex Hybrid | Cardiovascular | PMA Supplement | Approved (30-day notice) | P210006/S019 | Jun 24, 2026 | 29d | Oct 26, 2026 |
D DiaSorin, Inc. |
LIAISON® Biotrin Parvovirus B19 IgM Plus, LIAISON® Biotrin Control Parvovirus B19 IgM Plus | Diagnostics | PMA Supplement | Approved (30-day notice) | P250039/S001 | Jun 24, 2026 | 20d | Oct 26, 2026 |
I Integra Lifesciences Production Corporation |
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) … | Neurology | 510(k) | Cleared | K261004 | Jun 23, 2026 | 89d | Oct 26, 2026 |
C CG Bio Co., Ltd. |
Curasys 2 (Emdn0003) | Surgical | 510(k) | Cleared | K253199 | Jun 23, 2026 | 270d | Oct 26, 2026 |
M Microlife Corporation |
Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Anesthesiology | 510(k) | Cleared | K253180 | Jun 23, 2026 | 270d | Oct 26, 2026 |
P Procept Biorobotics |
AQUABEAM Robotic System | Surgical | 510(k) | Cleared | K253211 | Jun 23, 2026 | 267d | Oct 26, 2026 |
M Merz North America, Inc. |
Belotero Volume (+) Lidocaine | Surgical | PMA Supplement | Approved (30-day notice) | P250020/S003 | Jun 23, 2026 | 26d | Oct 26, 2026 |
W W. L. Gore & Associates, Inc. |
GORE® EXCLUDER® AAA Endoprosthesis | Cardiovascular | PMA Supplement | Approved (30-day notice) | P020004/S208 | Jun 23, 2026 | 25d | Oct 26, 2026 |
K Kardium, Inc. |
Globe® Catheter and Globe® Pulsed Field System | Cardiovascular | PMA Supplement | Approved | P240044/S001 | Jun 23, 2026 | 267d | Oct 26, 2026 |
C Cordis US Corporation |
Exoseal Vascular Closure Device | Cardiovascular | PMA Supplement | Approved | P100013/S034 | Jun 23, 2026 | 25d | Oct 26, 2026 |
N Nexus Spine |
DeltaNEC Interbody System | Orthopedic | 510(k) | Cleared | K261279 | Jun 22, 2026 | 66d | Oct 26, 2026 |
G GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. |
Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | Physical Medicine | 510(k) | Cleared | K261076 | Jun 22, 2026 | 82d | Oct 26, 2026 |
L LBDO Group, Inc. |
Flow Water-Based Personal Lubricant | Women's Health | 510(k) | Cleared | K254011 | Jun 22, 2026 | 189d | Oct 26, 2026 |
H Health Line International Corporation |
Health Line Tearaway Introducer | Cardiovascular | 510(k) | Cleared | K261950 | Jun 22, 2026 | 12d | Oct 26, 2026 |
G GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. |
Manual Wheelchair (MS01);Manual Wheelchair (MA01) | Physical Medicine | 510(k) | Cleared | K261075 | Jun 22, 2026 | 82d | Oct 26, 2026 |
V Vivaquant, Inc. Dba Rhythm Express |
RX-1 Sleep | Anesthesiology | 510(k) | Cleared | K253148 | Jun 22, 2026 | 270d | Oct 26, 2026 |
Q Quantified Imaging Limited |
Perfusion Measurement Platform v1 | Imaging | 510(k) | Cleared | K253421 | Jun 22, 2026 | 264d | Oct 26, 2026 |
M Medline Industries, LP |
Medline Reusable Blood Pressure Cuff | Cardiovascular | 510(k) | Cleared | K254287 | Jun 22, 2026 | 173d | Oct 26, 2026 |
P Prodeon Medical, Inc. |
Urocross Expander System (UES-2018-C1) | Other | 510(k) | Cleared | K261342 | Jun 22, 2026 | 60d | Oct 26, 2026 |
B Beyond 700 Pty, Ltd. |
TearView | Ophthalmic | 510(k) | Cleared | K253176 | Jun 22, 2026 | 269d | Oct 26, 2026 |
C Cercare Medical A/S |
CMN Capillary Function with Oncology Virtual Expert | Imaging | 510(k) | Cleared | K260316 | Jun 22, 2026 | 143d | Oct 26, 2026 |
L Lungpacer Medical USA, Inc. |
AeroPace® System | Anesthesiology | PMA Supplement | Approved | P240012/S007 | Jun 22, 2026 | 27d | Oct 26, 2026 |
B Bard Peripheral Vascular, Inc. |
Fluency Plus Endovascular Stent Graft | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130029/S015 | Jun 22, 2026 | 26d | Oct 26, 2026 |
L Lung Bioengineering, Inc. |
LungFX device | Other | PMA | Approved | P240033 | Jun 22, 2026 | 630d | Oct 26, 2026 |
Q Q-Med AB |
SCULPTRA® (injectable poly-L Lactic acid) | Surgical | PMA Supplement | Approved (30-day notice) | P030050/S055 | Jun 22, 2026 | 26d | Oct 26, 2026 |
B Biotronik AG |
Astron Peripheral Self-Expanding Nitinol Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140030/S024 | Jun 22, 2026 | 12d | Oct 26, 2026 |
A Abbott Medical |
Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves | Cardiovascular | PMA Supplement | Approved | P040021/S061 | Jun 22, 2026 | 182d | Oct 26, 2026 |
H Heartsine Technologies, Ltd. |
HeartSine® samaritan® (SAM) Public Access Defibrillator (PAD) SAM 350P, SAM 360P and SAM 450P and Accessories | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160008/S035 | Jun 22, 2026 | 14d | Oct 26, 2026 |
B Biotronik AG |
Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160025/S025 | Jun 22, 2026 | 12d | Oct 26, 2026 |
A Abbott Molecular, Inc. |
Alinity m HR HPV | Diagnostics | PMA Supplement | Approved (30-day notice) | P230003/S018 | Jun 22, 2026 | 27d | Oct 26, 2026 |
A Abbott Medical |
Volt Pfa Catheter, Sensor Enabled | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250022/S007 | Jun 22, 2026 | 25d | Oct 26, 2026 |
L Lungpacer Medical USA, Inc. |
AeroPace® System | Anesthesiology | PMA Supplement | Approved | P240012/S006 | Jun 22, 2026 | 81d | Oct 26, 2026 |
L LEM Surgical AG |
Dynamis Robotic Surgical System | Neurology | 510(k) | Cleared | K260369 | Jun 20, 2026 | 135d | Oct 19, 2026 |
M Micro-Energy Medical Technology Co., Ltd. |
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Surgical | 510(k) | Cleared | K261701 | Jun 18, 2026 | 27d | Oct 19, 2026 |
S Shenzhen Ziqing Medical Equipment Co., Ltd. |
Wrist Blood Pressure Monitor (XW-05) | Cardiovascular | 510(k) | Cleared | K253126 | Jun 18, 2026 | 266d | Oct 19, 2026 |
T True Indicating, LLC |
InstaTRU Instant Biological Indicator for Steam (IBI-05) | General Hospital | 510(k) | Cleared | K251559 | Jun 18, 2026 | 393d | Oct 19, 2026 |
W W&H Dentalwerk Buermoos GmbH |
Implantmed Plus II & Piezomed Plus II Module | Dental | 510(k) | Cleared | K253776 | Jun 18, 2026 | 204d | Oct 19, 2026 |
S Shenzhen Root Innovation Technology Co., Ltd. |
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Women's Health | 510(k) | Cleared | K254254 | Jun 18, 2026 | 171d | Oct 19, 2026 |
R ROPCA ApS |
Arthur | Imaging | 510(k) | Cleared | K260190 | Jun 18, 2026 | 147d | Oct 19, 2026 |
S Sol-Millennium Medical, Inc. |
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | General Hospital | 510(k) | Cleared | K253110 | Jun 18, 2026 | 267d | Oct 19, 2026 |
V Vieworks Co., Ltd. |
Vivix-S 4386W (Fxrd-4386Wa) | Imaging | 510(k) | Cleared | K260820 | Jun 18, 2026 | 97d | Oct 19, 2026 |
F FUJIFILM Healthcare Americas Corporation |
Synapse PACS (7.6.0) | Imaging | 510(k) | Cleared | K261713 | Jun 18, 2026 | 27d | Oct 19, 2026 |
G Guangdong Newdermo Biotech Co., Ltd. |
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Surgical | 510(k) | Cleared | K260946 | Jun 18, 2026 | 87d | Oct 19, 2026 |
S Shantou Institute of Ultrasonic Instruments Co., Ltd. |
Portable DR Imaging System | Imaging | 510(k) | Cleared | K253058 | Jun 18, 2026 | 269d | Oct 19, 2026 |
Z Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Power Wheelchair (W5915B, W5915C, W5915D) | Physical Medicine | 510(k) | Cleared | K253812 | Jun 18, 2026 | 202d | Oct 19, 2026 |
H Hycor Biomedical |
NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum) … | Diagnostics | 510(k) | Cleared | K260280 | Jun 18, 2026 | 140d | Oct 19, 2026 |
E Ecm Therapeutics, Inc. |
Ecmt-100 Wmd | Other | 510(k) | Cleared | K253521 | Jun 18, 2026 | 217d | Oct 19, 2026 |
D Daxor Corporation |
Blood Volume Analyzer (200) | Diagnostics | 510(k) | Cleared | K261099 | Jun 18, 2026 | 77d | Oct 19, 2026 |
G GC America, Inc. |
Srgc-06 | Dental | 510(k) | Cleared | K261246 | Jun 18, 2026 | 63d | Oct 19, 2026 |
T The Surgeon General, Department of the Army (TSG-DA) |
3D MAC Titanium Cranial Plate (TCP) System | Neurology | 510(k) | Cleared | K253116 | Jun 18, 2026 | 267d | Oct 19, 2026 |
A A.B. Dental Devices , Ltd. |
Dental Implant System | Dental | 510(k) | Cleared | K250806 | Jun 18, 2026 | 458d | Oct 19, 2026 |
P Providence Medical Technology, Inc. |
CORUS Navigation System-GN | Neurology | 510(k) | Cleared | K261665 | Jun 18, 2026 | 29d | Oct 19, 2026 |
Z Zywie, Inc. |
ZywieZ3 Sensor & Adhesive | Cardiovascular | 510(k) | Cleared | K252839 | Jun 18, 2026 | 286d | Oct 19, 2026 |
A Avalign Technologies, Inc. |
CONDUIT ZERO-P VA Secured Spacer System | Orthopedic | 510(k) | Cleared | K252982 | Jun 18, 2026 | 274d | Oct 19, 2026 |
P Presage Security, Inc. d/b/a Presage Technologies, Inc. |
SmartSpectra Vital Signs Monitor 1.0 | Cardiovascular | 510(k) | Cleared | K254169 | Jun 18, 2026 | 177d | Oct 19, 2026 |
G Guangzhou Rebornendo Medical Instrument Co., Ltd. |
Curing Light (M-Cure 6) | Dental | 510(k) | Cleared | K253131 | Jun 18, 2026 | 266d | Oct 19, 2026 |
S Suzhou and Science & Technology Development Corp. |
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Orthopedic | 510(k) | Cleared | K253080 | Jun 18, 2026 | 268d | Oct 19, 2026 |
S Siemens Medical Solutions USA, Inc. |
MAMMOMAT B.brilliant (11372950) | Imaging | 510(k) | Cleared | K253678 | Jun 18, 2026 | 209d | Oct 19, 2026 |
C Corcym S.r.l. |
MEMO 4D Curve Semirigid mitral annuloplasty ring | Cardiovascular | 510(k) | Cleared | K261707 | Jun 18, 2026 | 27d | Oct 19, 2026 |
S Shenzhen Konmed Technology Co., Ltd. |
Pelvic Muscle Trainer (KM510, KM516B) | Other | 510(k) | Cleared | K260178 | Jun 18, 2026 | 148d | Oct 19, 2026 |
S Stryker Sustainability Solutions |
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Surgical | 510(k) | Cleared | K260636 | Jun 18, 2026 | 112d | Oct 19, 2026 |
A Autonomous Healthcare, Inc. |
Syncron-E | Anesthesiology | De Novo | Granted | DEN250025 | Jun 18, 2026 | 360d | Oct 19, 2026 |
V Vincent Healthcare Products Limited |
inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009) … | Anesthesiology | 510(k) | Cleared | K252066 | Jun 18, 2026 | 352d | Oct 19, 2026 |
M Mastel Surgical |
SteriBest® Sterilization Tray System | General Hospital | 510(k) | Cleared | K253187 | Jun 18, 2026 | 265d | Oct 19, 2026 |
K Kanglongda Vietnam Protection Technology Company Limited |
Powder Free Nitrile Examination Gloves Non-Sterile Black | General Hospital | 510(k) | Cleared | K253824 | Jun 18, 2026 | 199d | Oct 19, 2026 |
M Megagen Implant Co., Ltd. |
MegaGen Zygoma Dental Implant System | Dental | 510(k) | Cleared | K251232 | Jun 18, 2026 | 422d | Oct 19, 2026 |
I Informai |
RadOncAI | Imaging | 510(k) | Cleared | K253050 | Jun 18, 2026 | 269d | Oct 19, 2026 |
G GuideAI Health |
Vascular Assist Occlusion Triage (VAOT) (v1.0) | Imaging | 510(k) | Cleared | K260729 | Jun 18, 2026 | 104d | Oct 19, 2026 |
N NuVasive Specialized Orthopedics |
Precice Max System and Precice Ankle Salvage System | Orthopedic | 510(k) | Cleared | K261651 | Jun 18, 2026 | 30d | Oct 19, 2026 |
L LivaNova USA, Inc. |
aura6000 system | Anesthesiology | PMA Supplement | Approved | P250013/S002 | Jun 18, 2026 | 30d | Oct 19, 2026 |
M Mobia Medical, Inc. |
Vivistim Pair VNS System | Physical Medicine | PMA Supplement | Approved (30-day notice) | P210007/S014 | Jun 18, 2026 | 27d | Oct 19, 2026 |
B Bolton Medical, Inc. |
TREO® Abdominal Stent-Graft System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P190015/S030 | Jun 18, 2026 | 29d | Oct 19, 2026 |
E Edwards Lifesciences, LLC |
PASCAL Precision Transcatheter Valve Repair System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P220003/S030 | Jun 18, 2026 | 27d | Oct 19, 2026 |
B Bolton Medical, Inc. |
RelayPro Thoracic Stent-Graft System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200045/S024 | Jun 18, 2026 | 29d | Oct 19, 2026 |
H Hepquant, LLC |
HepQuant SHUNT® Liver Diagnostic Test | Diagnostics | PMA | Approved | P220016 | Jun 18, 2026 | 1373d | Oct 19, 2026 |
O Oneness Biotech Co., Ltd. |
Bonvadis® | Other | 510(k) | Cleared | K261638 | Jun 17, 2026 | 30d | Oct 19, 2026 |
A Abbott Medical |
Amplatzer TorqVue Exchange System | Cardiovascular | 510(k) | Cleared | K261631 | Jun 17, 2026 | 30d | Oct 19, 2026 |
H Hua Yue Medical Technology Co., Ltd. |
Assisted Reproduction Laser System (Model ILS-400M) | Women's Health | 510(k) | Cleared | K253333 | Jun 17, 2026 | 260d | Oct 19, 2026 |
H Honsun (Nantong) Co., Ltd. |
Portable Oxygen Concentrator | Anesthesiology | 510(k) | Cleared | K252399 | Jun 17, 2026 | 321d | Oct 19, 2026 |
P Portal Access, Inc. |
FLEXI-PORT Power Injectable Implantable Port | General Hospital | 510(k) | Cleared | K260916 | Jun 17, 2026 | 90d | Oct 19, 2026 |
S Shenzhen Root Innovation Technology Co., Ltd. |
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Women's Health | 510(k) | Cleared | K260538 | Jun 17, 2026 | 120d | Oct 19, 2026 |
I Inosys, Inc. |
INOSS System | Dental | 510(k) | Cleared | K260006 | Jun 17, 2026 | 166d | Oct 19, 2026 |
C Cynosure, LLC |
Picosure Workstation | Surgical | 510(k) | Cleared | K261570 | Jun 17, 2026 | 36d | Oct 19, 2026 |
S Socko Medical Co., Ltd. |
Socko Vimax Spinal Fixation System | Orthopedic | 510(k) | Cleared | K253045 | Jun 17, 2026 | 268d | Oct 19, 2026 |
B Beijing Fule Science & Technology Development Co., Ltd. |
Fule Metallic Lockable Intramedullary Nail Systems | Orthopedic | 510(k) | Cleared | K253155 | Jun 17, 2026 | 264d | Oct 19, 2026 |
B Boston Scientific Corporation |
RIVOS EUS Access Device (M00553900) | Other | 510(k) | Cleared | K260428 | Jun 17, 2026 | 127d | Oct 19, 2026 |
F Foshan Pingchuang Medical Technology Co., Ltd. |
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Imaging | 510(k) | Cleared | K253255 | Jun 17, 2026 | 261d | Oct 19, 2026 |
D Deka Research and Development |
twiist Automated Insulin Delivery (AID) System | Diagnostics | 510(k) | Cleared | K261672 | Jun 17, 2026 | 27d | Oct 19, 2026 |
H Hartalega NGC Sdn. Bhd. |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) … | General Hospital | 510(k) | Cleared | K260867 | Jun 17, 2026 | 92d | Oct 19, 2026 |
H Hologic, Inc. |
CoolSeal Generator® (CSL-200-90) | Surgical | 510(k) | Cleared | K253634 | Jun 17, 2026 | 210d | Oct 19, 2026 |
S Stryker Instruments |
Hydro Irrigation System | Other | 510(k) | Cleared | K261544 | Jun 17, 2026 | 40d | Oct 19, 2026 |
N Nordic Kinetics AB |
Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | Neurology | 510(k) | Cleared | K253055 | Jun 17, 2026 | 268d | Oct 19, 2026 |
N NeuroPace, Inc. |
NeuroPace® RNS® System | Neurology | PMA Supplement | Approved | P100026/S100 | Jun 17, 2026 | 328d | Oct 19, 2026 |
A Abbott Medical |
AVEIR Patient Transmitter LSRM01 | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150035/S040 | Jun 17, 2026 | 29d | Oct 19, 2026 |
B Boston Scientific Corporation |
Axonics SNM System | Other | PMA Supplement | Approved (30-day notice) | P190006/S112 | Jun 17, 2026 | 27d | Oct 19, 2026 |
B Boston Scientific Corporation |
Axonics SNM System | Other | PMA Supplement | Approved (30-day notice) | P180046/S112 | Jun 17, 2026 | 27d | Oct 19, 2026 |
P Pulmonx Corporation |
Zephyr Endobronchial Valve (EBV) System | Anesthesiology | PMA Supplement | Approved (30-day notice) | P180002/S031 | Jun 17, 2026 | 26d | Oct 19, 2026 |
M Merz North America, Inc. |
Belotero Volume (+) Lidocaine | Surgical | PMA Supplement | Approved (30-day notice) | P250020/S001 | Jun 17, 2026 | 28d | Oct 19, 2026 |
F Ferrosan Meidcal Devices A/S |
SURGIFOAM® Absorbable Gelatin Sponge | Surgical | PMA Supplement | Approved (30-day notice) | P990004/S081 | Jun 17, 2026 | 26d | Oct 19, 2026 |
S Shenzhen Kaiyan Medical Equipment Co., Ltd. |
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Surgical | 510(k) | Cleared | K254025 | Jun 16, 2026 | 182d | Oct 19, 2026 |
Z Zimmer, Inc. |
Augment Off-Axis Instrument System | Orthopedic | 510(k) | Cleared | K261683 | Jun 16, 2026 | 26d | Oct 19, 2026 |
Z ZheJiang Decans Medical Devices Co., Ltd. |
HERA Interlocking Intramedullary Nailing System | Orthopedic | 510(k) | Cleared | K253046 | Jun 16, 2026 | 267d | Oct 19, 2026 |
H Hivox Biotek, Inc. |
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Neurology | 510(k) | Cleared | K260425 | Jun 16, 2026 | 126d | Oct 19, 2026 |
I I.T.S. GmbH |
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability … | Orthopedic | 510(k) | Cleared | K260958 | Jun 16, 2026 | 85d | Oct 19, 2026 |
D Diazyme Laboratories, Inc. |
Lipoprotein (a) Molarity Assay | Diagnostics | 510(k) | Cleared | K253069 | Jun 16, 2026 | 266d | Oct 19, 2026 |
8 80 Beats Medical GmbH |
VicorderCS (VCS-SYS-1100) | Cardiovascular | 510(k) | Cleared | K260693 | Jun 16, 2026 | 105d | Oct 19, 2026 |
N Neurent Medical , Ltd. |
NEUROMARK System (NMK00301) | Surgical | 510(k) | Cleared | K261833 | Jun 16, 2026 | 14d | Oct 19, 2026 |
Z Zimmer, Inc. |
Z1 Hip System | Orthopedic | 510(k) | Cleared | K260831 | Jun 16, 2026 | 95d | Oct 19, 2026 |
S Siemens Medical Solutions USA, Inc. |
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System … | Imaging | 510(k) | Cleared | K260844 | Jun 16, 2026 | 92d | Oct 19, 2026 |
F Fujifilm Corporation |
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Other | 510(k) | Cleared | K253137 | Jun 16, 2026 | 264d | Oct 19, 2026 |
M Medpark Co., Ltd. |
BOSS | Dental | 510(k) | Cleared | K253723 | Jun 16, 2026 | 204d | Oct 19, 2026 |
E Empirical Spine |
LimiFlex® Dynamic Sagittal Tether Instrument Set | Orthopedic | 510(k) | Cleared | K253374 | Jun 16, 2026 | 259d | Oct 19, 2026 |
H Hunan Ruijiong Biotech Co., Ltd. |
KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Anesthesiology | 510(k) | Cleared | K253001 | Jun 16, 2026 | 270d | Oct 19, 2026 |
Z Zdeer Technology (Henan) Co., Ltd. |
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Physical Medicine | 510(k) | Cleared | K260899 | Jun 16, 2026 | 90d | Oct 19, 2026 |
H Hubei Yjt Technology Co.,Ltd |
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552 … | Physical Medicine | 510(k) | Cleared | K253231 | Jun 16, 2026 | 260d | Oct 19, 2026 |
W Wright Medical Technology, Inc. (Stryker) |
Prophecy Incompass Surgical Planning System | Orthopedic | 510(k) | Cleared | K253159 | Jun 16, 2026 | 263d | Oct 19, 2026 |
S Siemens Healthcare GmbH |
myAblation Guide (VC10A) | Imaging | 510(k) | Cleared | K253264 | Jun 16, 2026 | 260d | Oct 19, 2026 |
M Medtronic Neuromodulation |
InterStim Therapy System, Verify Evaluation System | Other | PMA Supplement | Approved (30-day notice) | P080025/S349 | Jun 16, 2026 | 19d | Oct 19, 2026 |
C CooperVision, Inc. |
comflicon A Soft (Hydrophilic) Contact Lenses for Extended Wear | Ophthalmic | PMA Supplement | Approved (30-day notice) | P080011/S202 | Jun 16, 2026 | 29d | Oct 19, 2026 |
M Medtronic Neuromodulation |
InterStim Therapy System, Verify Evaluation System | Other | PMA Supplement | Approved (30-day notice) | P970004/S454 | Jun 16, 2026 | 19d | Oct 19, 2026 |
M Medtronic, Inc. |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense | Neurology | PMA Supplement | Approved (30-day notice) | P960009/S537 | Jun 16, 2026 | 19d | Oct 19, 2026 |
R Roche Molecular Systems, Inc. |
cobas HPV | Diagnostics | PMA Supplement | Approved | P190028/S023 | Jun 16, 2026 | 162d | Oct 19, 2026 |
M Medtronic Neuromodulation |
Altaviva | Other | PMA Supplement | Approved (30-day notice) | P240011/S014 | Jun 16, 2026 | 19d | Oct 19, 2026 |
K Kaneka Pharma America Corp. |
LIPOSORBER® LA-15 System | Other | PMA Supplement | Approved (30-day notice) | P910018/S042 | Jun 16, 2026 | 21d | Oct 19, 2026 |
W W. L. Gore & Associates, Inc. |
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160021/S052 | Jun 16, 2026 | 25d | Oct 19, 2026 |
D Defibtech, LLC |
Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO … | Cardiovascular | PMA Supplement | Approved | P160032/S015 | Jun 16, 2026 | 291d | Oct 19, 2026 |
M Medtronic Neuromodulation |
Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and … | Neurology | PMA Supplement | Approved (30-day notice) | P840001/S629 | Jun 16, 2026 | 19d | Oct 19, 2026 |
D Diasorin Molecular, LLC |
LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diagnostics | 510(k) | Cleared | K260333 | Jun 15, 2026 | 133d | Oct 19, 2026 |
D DeepHealth, Inc. |
Saige-Dx | Imaging | 510(k) | Cleared | K253825 | Jun 15, 2026 | 196d | Oct 19, 2026 |
J Jpi Healthcare Co, Ltd. |
DRE Duo | Imaging | 510(k) | Cleared | K260482 | Jun 15, 2026 | 122d | Oct 19, 2026 |
Z Zdeer Technology (Henan) Co., Ltd. |
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156 … | Other | 510(k) | Cleared | K260452 | Jun 15, 2026 | 124d | Oct 19, 2026 |
S Spine Wave, Inc. |
Dynamo Spinal Cement; Salvo® Spine System | Orthopedic | 510(k) | Cleared | K260286 | Jun 15, 2026 | 137d | Oct 19, 2026 |
G Gimbo Medical Technology Shenzhen Co., Ltd. |
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Women's Health | 510(k) | Cleared | K253121 | Jun 15, 2026 | 263d | Oct 19, 2026 |
J JJGC Indústria e Comércio de Materiais Dentários S.A. |
Neodent Scannable Healing Abutment | Dental | 510(k) | Cleared | K253922 | Jun 15, 2026 | 189d | Oct 19, 2026 |
U USpharma, Ltd. |
Curajel Oral Gel | Other | 510(k) | Cleared | K260126 | Jun 15, 2026 | 151d | Oct 19, 2026 |
T Tournicare Pty, Ltd. |
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Cardiovascular | 510(k) | Cleared | K253059 | Jun 15, 2026 | 266d | Oct 19, 2026 |
Z Zhongshan Sulenz Intelligent Technology Co., Ltd. |
Electric Wheelchair (S500-6) | Physical Medicine | 510(k) | Cleared | K260335 | Jun 15, 2026 | 133d | Oct 19, 2026 |
C Crescom Co., Ltd. |
MediAI-OA | Imaging | 510(k) | Cleared | K253172 | Jun 15, 2026 | 262d | Oct 19, 2026 |
L Luma Vision Limited |
VERAFEYE Imaging and Guidance System (VF-VIS-002) | Other | 510(k) | Cleared | K260885 | Jun 15, 2026 | 90d | Oct 19, 2026 |
A Anumana, Inc. |
WatchMate Software | Imaging | 510(k) | Cleared | K260300 | Jun 15, 2026 | 136d | Oct 19, 2026 |
M Medyssey Co, Ltd. |
NeckTune 3D SA Cervical Cage | Orthopedic | 510(k) | Cleared | K260036 | Jun 15, 2026 | 160d | Oct 19, 2026 |
O Orthocon, Inc. |
Permatage XT Settable Bone Putty | Neurology | 510(k) | Cleared | K261265 | Jun 15, 2026 | 60d | Oct 19, 2026 |
S Siemens Healthineers AG |
LungMaps | Imaging | 510(k) | Cleared | K253690 | Jun 15, 2026 | 206d | Oct 19, 2026 |
B Beijing Fule Science & Technology Development Co., Ltd. |
Fule Interbody Fusion Cage System | Orthopedic | 510(k) | Cleared | K253151 | Jun 15, 2026 | 262d | Oct 19, 2026 |
P Proverum, Ltd. |
ProVee System for BPH | Other | PMA Supplement | Approved (30-day notice) | P250011/S003 | Jun 15, 2026 | 28d | Oct 19, 2026 |
A Abiomed, Inc. |
Impella CP with SmartAssist | Cardiovascular | PMA Supplement | Approved | P140003/S138 | Jun 15, 2026 | 28d | Oct 19, 2026 |
N Neuroelectrics Barcelona S.L.U. |
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neurology | 510(k) | Cleared | K261604 | Jun 13, 2026 | 30d | Oct 12, 2026 |
P Polybell (Guangzhou) Limited |
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Women's Health | 510(k) | Cleared | K260346 | Jun 12, 2026 | 129d | Oct 12, 2026 |
D Dyne Medical Group, Inc. |
Dyne Port | Other | 510(k) | Cleared | K252933 | Jun 12, 2026 | 270d | Oct 12, 2026 |
B BTL Industries, Inc. |
Btl-899Tt | Physical Medicine | 510(k) | Cleared | K252963 | Jun 12, 2026 | 268d | Oct 12, 2026 |
K Konica Minolta Healthcare Americas, Inc. |
Universal 1417PI | Imaging | 510(k) | Cleared | K252996 | Jun 12, 2026 | 267d | Oct 12, 2026 |
S Somnomed, Inc. |
Virtus | Dental | 510(k) | Cleared | K261366 | Jun 12, 2026 | 46d | Oct 12, 2026 |
W Whill, Inc. |
WHILL (WHILL Model C2) | Physical Medicine | 510(k) | Cleared | K261175 | Jun 12, 2026 | 63d | Oct 12, 2026 |
N Nuvascular, Inc. |
HARBOR Occlusion Device | Cardiovascular | 510(k) | Cleared | K260635 | Jun 12, 2026 | 106d | Oct 12, 2026 |
S Stryker Corporation (Tornier, Inc.) |
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Orthopedic | 510(k) | Cleared | K260102 | Jun 12, 2026 | 150d | Oct 12, 2026 |
V VoxNeuro, Inc. |
Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | Neurology | 510(k) | Cleared | K253015 | Jun 12, 2026 | 266d | Oct 12, 2026 |
L Lg Electronics.Inc |
Medical Monitor (40HT513D) | Imaging | 510(k) | Cleared | K261213 | Jun 12, 2026 | 59d | Oct 12, 2026 |
B Brainomix Limited |
Brainomix 360 Hyperdensity | Imaging | 510(k) | Cleared | K260406 | Jun 12, 2026 | 123d | Oct 12, 2026 |
S Sanhe LEFIS Electronics Co., Ltd. |
Intense Pulsed Light Therapy Device | Surgical | 510(k) | Cleared | K261204 | Jun 12, 2026 | 60d | Oct 12, 2026 |
S Sutura Medical Technology, Inc. |
Barbed PDO Suture | Surgical | 510(k) | Cleared | K252171 | Jun 12, 2026 | 337d | Oct 12, 2026 |
B Bayer Medical Care, Inc. |
MEDRAD® Imaging Bulk Package Transfer Spike | General Hospital | 510(k) | Cleared | K253688 | Jun 12, 2026 | 203d | Oct 12, 2026 |
M Midmark Corporation |
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Cardiovascular | 510(k) | Cleared | K253196 | Jun 12, 2026 | 259d | Oct 12, 2026 |
C CMT Health PTE., Ltd. |
Profoject Safety Needle; Profoject Syringe with Safety Needle … | General Hospital | 510(k) | Cleared | K260514 | Jun 12, 2026 | 115d | Oct 12, 2026 |
S Spiro Robotics |
Spiro-VISTA | Anesthesiology | 510(k) | Cleared | K253437 | Jun 12, 2026 | 254d | Oct 12, 2026 |
T Tyber Medical, LLC |
Exalta Proximal Tibia Plating System | Orthopedic | 510(k) | Cleared | K261207 | Jun 12, 2026 | 60d | Oct 12, 2026 |
S SteriLance Medical (Suzhou), Inc. |
Disposable Blood Lancet (Soft) | Surgical | 510(k) | Cleared | K261634 | Jun 12, 2026 | 25d | Oct 12, 2026 |
D Dosisoft SA |
ThinkQA 3 | Imaging | 510(k) | Cleared | K252937 | Jun 12, 2026 | 270d | Oct 12, 2026 |
M Micropace Pty, Ltd. |
OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Cardiovascular | 510(k) | Cleared | K253088 | Jun 12, 2026 | 262d | Oct 12, 2026 |
R Roche Diagnostics |
cobas pulse blood glucose monitoring system | Diagnostics | 510(k) | Cleared | K252323 | Jun 12, 2026 | 322d | Oct 12, 2026 |
A Autonomous Medical Devices Incorporated |
Fast PCR Mini Respiratory Panel | Diagnostics | 510(k) | Cleared | K252932 | Jun 12, 2026 | 270d | Oct 12, 2026 |
D Dexcom, Inc. |
Stelo Glucose Biosensor System | Diagnostics | 510(k) | Cleared | K260935 | Jun 12, 2026 | 84d | Oct 12, 2026 |
E Epic Medical Pte. , Ltd. |
ADRx Admixture Device | General Hospital | 510(k) | Cleared | K252987 | Jun 12, 2026 | 267d | Oct 12, 2026 |
M Medtronic Neuromodulation |
InterStim® Therapy System | Other | PMA Supplement | Approved (30-day notice) | P080025/S348 | Jun 12, 2026 | 28d | Oct 12, 2026 |
C Croma-Pharma GmbH |
saypha® ChiQ | Surgical | PMA | Approved | P250021 | Jun 12, 2026 | 351d | Oct 12, 2026 |
V Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
VENTANA PTEN (SP218) RxDx Assay | Diagnostics | PMA | Approved | P250031 | Jun 12, 2026 | 298d | Oct 12, 2026 |
S Saluda Medical Pty, Ltd. |
Saluda Medical Evoke SCS System | Neurology | PMA Supplement | Approved (30-day notice) | P190002/S049 | Jun 12, 2026 | 28d | Oct 12, 2026 |
S Saluda Medical Pty, Ltd. |
Evoke SCS System | Neurology | PMA Supplement | Approved (30-day notice) | P190002/S048 | Jun 12, 2026 | 28d | Oct 12, 2026 |
M Medtronic Minimed, Inc. |
MiniMed 780G System | Diagnostics | PMA Supplement | Approved | P160017/S135 | Jun 12, 2026 | 133d | Oct 12, 2026 |
K Kardium, Inc. |
Globe® Catheter; Globe® Pulsed Field System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240044/S005 | Jun 12, 2026 | 25d | Oct 12, 2026 |
M Medtronic Minimed |
Simplera system | Diagnostics | PMA Supplement | Approved | P160007/S060 | Jun 12, 2026 | 133d | Oct 12, 2026 |
M Medtronic Neuromodulation |
InterStim® Therapy System | Other | PMA Supplement | Approved (30-day notice) | P970004/S453 | Jun 12, 2026 | 28d | Oct 12, 2026 |
M Medtronic Minimed, Inc. |
Simplera Sync Sensor | Diagnostics | PMA Supplement | Approved | P250012/S008 | Jun 12, 2026 | 133d | Oct 12, 2026 |
U Uneeg Medical A/S |
UNEEG EpiSight System | Neurology | 510(k) | Cleared | K253607 | Jun 11, 2026 | 205d | Oct 12, 2026 |
S SurGenTec, LLC |
Ion-L | Other | 510(k) | Cleared | K261209 | Jun 11, 2026 | 59d | Oct 12, 2026 |
H Hass Corp. |
Rosetta SM, Rosetta SP | Dental | 510(k) | Cleared | K260859 | Jun 11, 2026 | 87d | Oct 12, 2026 |
D Distalmotion SA |
Dexter L6 System | Surgical | 510(k) | Cleared | K260653 | Jun 11, 2026 | 104d | Oct 12, 2026 |
F FloShield, Inc. |
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm … | Other | 510(k) | Cleared | K260710 | Jun 11, 2026 | 99d | Oct 12, 2026 |
N Nuralogix Corporation |
Anura Mobile Core SDK (M1) | Cardiovascular | 510(k) | Cleared | K253650 | Jun 11, 2026 | 203d | Oct 12, 2026 |
A Avita Corporation |
AViTA Breast Pump | Women's Health | 510(k) | Cleared | K250129 | Jun 11, 2026 | 510d | Oct 12, 2026 |
S Synthes (USA) Products, LLC |
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Orthopedic | 510(k) | Cleared | K254087 | Jun 11, 2026 | 175d | Oct 12, 2026 |
I Instylla, Inc. |
Verge Microcatheter | Cardiovascular | 510(k) | Cleared | K261610 | Jun 11, 2026 | 28d | Oct 12, 2026 |
A Abbott Point of Care, Inc. |
i-STAT hs-TnI cartridge with the i-STAT Alinity System | Diagnostics | 510(k) | Cleared | K253051 | Jun 11, 2026 | 262d | Oct 12, 2026 |
H Hitachi High-Tech Corp. |
Probeat-Cr | Imaging | 510(k) | Cleared | K260174 | Jun 11, 2026 | 141d | Oct 12, 2026 |
P PR Personal Care Laboratories |
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | Women's Health | 510(k) | Cleared | K261292 | Jun 11, 2026 | 52d | Oct 12, 2026 |
C Changzhou Boen Zhongding Medical Technology Co., Ltd. |
Dental X-ray System | Imaging | 510(k) | Cleared | K250839 | Jun 11, 2026 | 448d | Oct 12, 2026 |
E Edwards Lifesciences, LLC |
Respiration Rate algorithm | Anesthesiology | 510(k) | Cleared | K251326 | Jun 11, 2026 | 408d | Oct 12, 2026 |
E Endeavor Commerce, LLC |
Snorbliss® Anti-Snoring Device | Dental | 510(k) | Cleared | K261251 | Jun 11, 2026 | 56d | Oct 12, 2026 |
N Nagy Oral Technology Qinhuangdao Co., Ltd. |
Fluoride Varnish (Type A,Type C) | Dental | 510(k) | Cleared | K253052 | Jun 11, 2026 | 262d | Oct 12, 2026 |
R Rehasense USA, Inc. |
Icon 35; Icon 45; Icon 60; Icon 30Faf | Physical Medicine | 510(k) | Cleared | K260849 | Jun 11, 2026 | 87d | Oct 12, 2026 |
M Mighty Oak Medical |
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Imaging | 510(k) | Cleared | K260322 | Jun 11, 2026 | 132d | Oct 12, 2026 |
S Smart Denture Conversions, LLC |
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Dental | 510(k) | Cleared | K254145 | Jun 11, 2026 | 171d | Oct 12, 2026 |
S Shenzhen Magnet Technology Co., Ltd. |
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Other | 510(k) | Cleared | K261256 | Jun 11, 2026 | 56d | Oct 12, 2026 |
B Biotronik AG |
Orsiro Mission Sirolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved | P170030/S058 | Jun 11, 2026 | 363d | Oct 12, 2026 |
M Merit Medical Systems, Inc. |
WRAPSODY® Cell-Impermeable Endoprosthesis | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240023/S005 | Jun 11, 2026 | 29d | Oct 12, 2026 |
A Abbott Medical |
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P810002/S126 | Jun 11, 2026 | 29d | Oct 12, 2026 |
M Medtronic, Inc. |
Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADVDD01, SED01, SEDR01, SES01) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P980035/S841 | Jun 11, 2026 | 22d | Oct 12, 2026 |
A Abbott Medical |
UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999 … | Cardiovascular | PMA Supplement | Approved | P960013/S133 | Jun 11, 2026 | 36d | Oct 12, 2026 |
A Allergan |
SKINVIVE by JUVEDERM® | Surgical | PMA Supplement | Approved | P110033/S099 | Jun 11, 2026 | 394d | Oct 12, 2026 |
A Abbott Medical |
UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999 … | Cardiovascular | PMA Supplement | Approved | P960030/S084 | Jun 11, 2026 | 36d | Oct 12, 2026 |
A Abbott Medical |
The AVEIR Leadless Pacemaker (LP) | Cardiovascular | PMA Supplement | Approved | P150035/S039 | Jun 11, 2026 | 29d | Oct 12, 2026 |
P Penumbra, Inc. |
Penumbra System (Thunderbolt Aspiration Tubing) | Cardiovascular | 510(k) | Cleared | K250690 | Jun 10, 2026 | 460d | Oct 12, 2026 |
R Rxsight, Inc. |
RxSight® Insertion Device | Ophthalmic | 510(k) | Cleared | K261174 | Jun 10, 2026 | 62d | Oct 12, 2026 |
D DNA Genotek, Inc. |
Colli-PeeDx Urine Collection Kit | Diagnostics | 510(k) | Cleared | K254121 | Jun 10, 2026 | 173d | Oct 12, 2026 |
X Xiamen Weiyou Intelligent Technology Co., Ltd. |
Cryo And Thermo Therapy System | Physical Medicine | 510(k) | Cleared | K253919 | Jun 10, 2026 | 184d | Oct 12, 2026 |
M Medacta International, SA |
MSS - Humeral reverse liners extension | Orthopedic | 510(k) | Cleared | K261016 | Jun 10, 2026 | 75d | Oct 12, 2026 |
C Centerline Biomedical |
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751) … | Cardiovascular | 510(k) | Cleared | K261329 | Jun 10, 2026 | 49d | Oct 12, 2026 |
T Tyber Medical, LLC |
Anteralign LS coverplate | Orthopedic | 510(k) | Cleared | K260810 | Jun 10, 2026 | 90d | Oct 12, 2026 |
S Sivantos GmbH |
Tinnitus Therapy | Other | 510(k) | Cleared | K260614 | Jun 10, 2026 | 105d | Oct 12, 2026 |
M Movmedix S.A.S. |
Lars Acj | Orthopedic | 510(k) | Cleared | K253115 | Jun 10, 2026 | 259d | Oct 12, 2026 |
T Tech-Image CO., LTD. |
Tech-Image Video Endoscope System | Other | 510(k) | Cleared | K260414 | Jun 10, 2026 | 121d | Oct 12, 2026 |
A Alpha Intelligence Manifolds, Inc. |
DeepXray Spina | Imaging | 510(k) | Cleared | K253192 | Jun 10, 2026 | 257d | Oct 12, 2026 |
C CMT Health PTE., Ltd. |
Profoject Safety Pen Needles | General Hospital | 510(k) | Cleared | K260855 | Jun 10, 2026 | 86d | Oct 12, 2026 |
C Carl Zeiss Meditec Production, LLC |
Ct Lucia 602, Ct Lucia 202, Ct Lucia 611P, Ct Lucia 621P | Ophthalmic | PMA Supplement | Approved (30-day notice) | P100016/S025 | Jun 10, 2026 | 27d | Oct 12, 2026 |
B Bard Peripheral Vascular, Inc. |
Venovo Venous Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P180037/S015 | Jun 10, 2026 | 19d | Oct 12, 2026 |
M Medibeacon, Inc. |
MediBeacon® Transdermal GFR Measurement System (TGFR) | Other | PMA Supplement | Approved | P230019/S002 | Jun 10, 2026 | 369d | Oct 12, 2026 |
C C.R. Bard, Inc. |
Covera Vascular Covered Stent | Cardiovascular | PMA Supplement | Approved (30-day notice) | P170042/S015 | Jun 10, 2026 | 19d | Oct 12, 2026 |
A Abbott Medical |
HeartMate II Left Ventricular Assist System (LVAS) | Cardiovascular | PMA Supplement | Approved | P060040/S124 | Jun 10, 2026 | 90d | Oct 12, 2026 |
G Guardant Health, Inc. |
Guardant360 CDx | Diagnostics | PMA Supplement | Approved | P200010/S027 | Jun 10, 2026 | 209d | Oct 12, 2026 |
B Bard Peripheral Vascular, Inc. |
Bard Fluency Plus Endovascular Stent Graft | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130029/S014 | Jun 10, 2026 | 19d | Oct 12, 2026 |
A Abbott Medical |
HeartMate 3 Left Ventricular Assist System (LVAS) | Cardiovascular | PMA Supplement | Approved | P160054/S125 | Jun 10, 2026 | 90d | Oct 12, 2026 |
B Bard Peripheral Vascular, Inc. |
LifeStent 5F Vascular Stent Systems | Cardiovascular | PMA Supplement | Approved (30-day notice) | P070014/S069 | Jun 10, 2026 | 19d | Oct 12, 2026 |
B Biosense Webster, Inc. |
THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS | Cardiovascular | PMA Supplement | Approved (30-day notice) | P030031/S144 | Jun 10, 2026 | 7d | Oct 12, 2026 |
T Terrats Medical SL |
DESS Dental Smart Solutions | Dental | 510(k) | Cleared | K260564 | Jun 9, 2026 | 110d | Oct 12, 2026 |
E E-Scopics |
ES-Series | Imaging | 510(k) | Cleared | K260748 | Jun 9, 2026 | 95d | Oct 12, 2026 |
C Chanpin Medtak Co., Ltd. |
ChanPin Pedicle Screw Spinal System | Orthopedic | 510(k) | Cleared | K251251 | Jun 9, 2026 | 412d | Oct 12, 2026 |
H Hathor Professional Skincare , Ltd. |
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Women's Health | 510(k) | Cleared | K252914 | Jun 9, 2026 | 270d | Oct 12, 2026 |
M MicroVention, Inc., d/b/a Terumo Neuro |
BOBBY Balloon Guide Catheter | Cardiovascular | 510(k) | Cleared | K261549 | Jun 9, 2026 | 29d | Oct 12, 2026 |
M Materialise NV |
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Orthopedic | 510(k) | Cleared | K260802 | Jun 9, 2026 | 90d | Oct 12, 2026 |
S Shenzhen TPH Technology Co., Ltd. |
Mother's Nature W1 Warming Wearable Breast Pump | Women's Health | 510(k) | Cleared | K260864 | Jun 9, 2026 | 84d | Oct 12, 2026 |
S Sejong Medical Co., Ltd. |
LAP-iX2N | Surgical | 510(k) | Cleared | K253165 | Jun 9, 2026 | 256d | Oct 12, 2026 |
T Theramicro |
TekBrace Solo Soft Tissue Reinforcement Device | Surgical | 510(k) | Cleared | K261621 | Jun 9, 2026 | 25d | Oct 12, 2026 |
E Erbe Elektromedizin GmbH |
ERBECRYO 2 Cryosurgical Unit and Accessories | Surgical | 510(k) | Cleared | K261806 | Jun 9, 2026 | 8d | Oct 12, 2026 |
M Medtronic, Inc. |
Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody … | Cardiovascular | PMA Supplement | Approved | P140017/S035 | Jun 9, 2026 | 75d | Oct 12, 2026 |
E Exact Sciences Corporation |
Cologuard® | Diagnostics | PMA Supplement | Approved (30-day notice) | P130017/S070 | Jun 9, 2026 | 18d | Oct 12, 2026 |
E Exact Sciences Corporation |
Cologuard Plus | Diagnostics | PMA Supplement | Approved (30-day notice) | P230043/S009 | Jun 9, 2026 | 18d | Oct 12, 2026 |
B Boston Scientific |
Ld Ingevity Plus Af | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150012/S188 | Jun 9, 2026 | 29d | Oct 12, 2026 |
B Boston Scientific Corp |
ACUITY SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010012/S611 | Jun 9, 2026 | 29d | Oct 12, 2026 |
B Boston Scientific |
RELIANCE S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P910073/S192 | Jun 9, 2026 | 29d | Oct 12, 2026 |
O One Ortho |
2D Hip Planning Software | Imaging | 510(k) | Cleared | K261352 | Jun 8, 2026 | 45d | Oct 12, 2026 |
O Onkos Surgical, Inc. |
ELEOS with NanoCept® Technology Limb Salvage System | Orthopedic | 510(k) | Cleared | K253066 | Jun 8, 2026 | 259d | Oct 12, 2026 |
P Pathwai, Inc. |
EchoNext | Cardiovascular | 510(k) | Cleared | K260332 | Jun 8, 2026 | 126d | Oct 12, 2026 |
D Dexcom, Inc. |
Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Diagnostics | 510(k) | Cleared | K261402 | Jun 8, 2026 | 40d | Oct 12, 2026 |
L Lipocosm, LLC |
Lipocosm Harmonic System | Surgical | 510(k) | Cleared | K251944 | Jun 8, 2026 | 349d | Oct 12, 2026 |
J Jiangsu Intco Medical Products Co., Ltd. |
Virgo Mobility Scooter (Virgo-D,Virgo-F) | Physical Medicine | 510(k) | Cleared | K253257 | Jun 8, 2026 | 252d | Oct 12, 2026 |
W Weero Co., Ltd. |
Apollo Quattro (APQ-10M) | Physical Medicine | 510(k) | Cleared | K253542 | Jun 8, 2026 | 206d | Oct 12, 2026 |
L Life Technologies Corporation |
Oncomine Dx Express Test | Diagnostics | PMA Supplement | Approved (30-day notice) | P240040/S006 | Jun 8, 2026 | 27d | Oct 12, 2026 |
N Nyxoah S.A. |
Genio® System 2.1 | Anesthesiology | PMA Supplement | Approved | P240024/S003 | Jun 8, 2026 | 91d | Oct 12, 2026 |
R Rxsight, Inc. |
RxSight Light Adjustable Lens; Light Delivery Device | Ophthalmic | PMA Supplement | Approved | P160055/S055 | Jun 8, 2026 | 52d | Oct 12, 2026 |
B Baxter Healthcare Corporation |
PerClot® Polysaccharide Hemostatic System | Surgical | PMA Supplement | Approved | P210036/S007 | Jun 8, 2026 | 167d | Oct 12, 2026 |
A Abbott Molecular, Inc. |
Alinity m HR HPV Assay | Diagnostics | PMA Supplement | Approved | P230003/S014 | Jun 8, 2026 | 87d | Oct 12, 2026 |
S Steps Ortho |
VEOFIX Snap Off Screw | Orthopedic | 510(k) | Cleared | K253108 | Jun 5, 2026 | 254d | Oct 5, 2026 |
U Unimed Medical Supplies, Inc. |
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG) … | General Hospital | 510(k) | Cleared | K253162 | Jun 5, 2026 | 252d | Oct 5, 2026 |
B BioTissue Holdings, Inc. |
Catalyze | Other | 510(k) | Cleared | K253204 | Jun 5, 2026 | 252d | Oct 5, 2026 |
A Assure Tech., LLC |
Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Diagnostics | 510(k) | Cleared | K260754 | Jun 5, 2026 | 88d | Oct 5, 2026 |
H Hangzhou Qiantang Longyue Biotechnology Co., Ltd. |
Vial Adapter | General Hospital | 510(k) | Cleared | K260301 | Jun 5, 2026 | 126d | Oct 5, 2026 |
A Allengers Medical Systems Limited |
Digital C-ARM with 3D | Imaging | 510(k) | Cleared | K253296 | Jun 5, 2026 | 249d | Oct 5, 2026 |
Z Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Power Wheelchair (N5515A, N5516, N5517A, N5519) | Physical Medicine | 510(k) | Cleared | K260056 | Jun 5, 2026 | 148d | Oct 5, 2026 |
M Medartis AG |
APTUS Clavicle System 2.8 | Orthopedic | 510(k) | Cleared | K260761 | Jun 5, 2026 | 88d | Oct 5, 2026 |
A Alma Lasers, Inc. |
Alma TED+ System | Physical Medicine | 510(k) | Cleared | K251684 | Jun 5, 2026 | 368d | Oct 5, 2026 |
N Nextstep Arthopedix, LLC |
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Orthopedic | 510(k) | Cleared | K243192 | Jun 5, 2026 | 613d | Oct 5, 2026 |
B Balosmark, Inc. |
Perfect-O Ostial Positioning Catheter | Cardiovascular | 510(k) | Cleared | K260289 | Jun 5, 2026 | 127d | Oct 5, 2026 |
E Edwards Lifesciences |
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Cardiovascular | 510(k) | Cleared | K260105 | Jun 5, 2026 | 143d | Oct 5, 2026 |
C CenterPoint Systems, LLC |
FieldFlex Steerable Sheath | Cardiovascular | 510(k) | Cleared | K261492 | Jun 5, 2026 | 30d | Oct 5, 2026 |
O Oculogica, Inc. |
EyeBOX SNAP | Neurology | 510(k) | Cleared | K254086 | Jun 5, 2026 | 169d | Oct 5, 2026 |
M Medtronic Sofamor Danek USA, Inc. |
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | Surgical | 510(k) | Cleared | K253656 | Jun 5, 2026 | 197d | Oct 5, 2026 |
B Biotronik Nro, Inc. |
Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead; Embrace One; TrueLock | Neurology | PMA Supplement | Approved (30-day notice) | P210037/S017 | Jun 5, 2026 | 28d | Oct 5, 2026 |
M Medtronic, Inc. |
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (B35200) | Neurology | PMA Supplement | Approved (30-day notice) | P960009/S536 | Jun 5, 2026 | 28d | Oct 5, 2026 |
M Medtronic Vascular |
Resolute Onyx Zotarolimus-Eluting Coronary Stent System … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160043/S094 | Jun 5, 2026 | 29d | Oct 5, 2026 |
O Organox Limited |
OrganOx metra® System | Other | PMA Supplement | Approved (30-day notice) | P200035/S039 | Jun 5, 2026 | 28d | Oct 5, 2026 |
B Biotronik AG |
PRO-Kinetic Energy Coronary Stent System | Cardiovascular | PMA Supplement | Approved | P160003/S024 | Jun 5, 2026 | 457d | Oct 5, 2026 |
C Cordis US Corporation |
PRECISE PRO RX Nitinol Stent System | Cardiovascular | PMA Supplement | Approved | P030047/S055 | Jun 5, 2026 | 29d | Oct 5, 2026 |
M Medtronic Neuromodulation |
InterStim TM Therapy System; Verify TM Evaluation System (97800) | Other | PMA Supplement | Approved (30-day notice) | P970004/S452 | Jun 5, 2026 | 28d | Oct 5, 2026 |
A Abbott Medical |
FlexAbility Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110016/S094 | Jun 5, 2026 | 35d | Oct 5, 2026 |
A Abbott Medical |
TactiFlex Ablation Catheter, Sensor Enabled | Cardiovascular | PMA Supplement | Approved (30-day notice) | P220013/S031 | Jun 5, 2026 | 35d | Oct 5, 2026 |
M Medtronic Neuromodulation |
InterStim TM Therapy System; Verify TM Evaluation System (97800) | Other | PMA Supplement | Approved (30-day notice) | P080025/S347 | Jun 5, 2026 | 28d | Oct 5, 2026 |
F Farapulse, Inc. |
FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230030/S021 | Jun 5, 2026 | 17d | Oct 5, 2026 |
M Medtronic Neuromodulation |
Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and … | Neurology | PMA Supplement | Approved (30-day notice) | P840001/S628 | Jun 5, 2026 | 28d | Oct 5, 2026 |
B Biotronik AG |
Orsiro Mission Sirolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved | P170030/S052 | Jun 5, 2026 | 457d | Oct 5, 2026 |
Z ZOLL Medical Corporation |
CPR Uni-padz Electrode | Cardiovascular | PMA Supplement | Approved | P160022/S051 | Jun 5, 2026 | 87d | Oct 5, 2026 |
C Cyndrx, LLC |
AbsorbaSeal 5.6.7F Vascular Closure Device | Cardiovascular | PMA | Approved | P230038 | Jun 5, 2026 | 931d | Oct 5, 2026 |
S St Jude Medical |
TactiCath Contact Force Ablation Catheter, Sensor Enabled | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130026/S100 | Jun 5, 2026 | 35d | Oct 5, 2026 |
O Occlutech Holding AG |
Occlutech® ASD Occluder and Occlutech® Pistol Pusher | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200032/S006 | Jun 5, 2026 | 29d | Oct 5, 2026 |
V Varian Medical Systems, Inc. |
Respiratory Gating for Scanners (2.1) | Imaging | 510(k) | Cleared | K253026 | Jun 4, 2026 | 258d | Oct 5, 2026 |
D DiaSorin, Inc. |
LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | Diagnostics | 510(k) | Cleared | K260770 | Jun 4, 2026 | 87d | Oct 5, 2026 |
C Covidien, LLC |
Instrument Exit Point on Touch Surgery Aide | Other | 510(k) | Cleared | K253984 | Jun 4, 2026 | 174d | Oct 5, 2026 |
A American Medical Endoscopy, Inc. |
Strauss Surgical Resection Instruments | Women's Health | 510(k) | Cleared | K253020 | Jun 4, 2026 | 258d | Oct 5, 2026 |
U Uzinmedicare Co., Ltd. |
Spectra Platinum Mini | Women's Health | 510(k) | Cleared | K260956 | Jun 4, 2026 | 73d | Oct 5, 2026 |
K Keya Medical Technology Co., Ltd. |
DEEPVESSEL Plaque | Imaging | 510(k) | Cleared | K260497 | Jun 4, 2026 | 111d | Oct 5, 2026 |
N New York Embroidery Studio (NYES) |
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | Surgical | 510(k) | Cleared | K252575 | Jun 4, 2026 | 294d | Oct 5, 2026 |
G Gt Metabolic Solutions, Inc. |
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Surgical | 510(k) | Cleared | K253102 | Jun 4, 2026 | 253d | Oct 5, 2026 |
B Beijing Sano Laser S&T Development Co.,Ltd |
LumiGlam Laser System (SHE-LSP601-3) | Surgical | 510(k) | Cleared | K260690 | Jun 4, 2026 | 93d | Oct 5, 2026 |
T Topcon Healthcare Solutions EMEA Oy |
Harmony Referral System with Harmony OCT Viewer (Octave) | Imaging | 510(k) | Cleared | K253893 | Jun 4, 2026 | 182d | Oct 5, 2026 |
T TroCare, LLC |
TroKit Laparoscope Lens Wiper | Other | 510(k) | Cleared | K253994 | Jun 4, 2026 | 174d | Oct 5, 2026 |
Y Yofo Medical Technology Co., Ltd. |
Dental Cone Beam Computed Tomography System | Imaging | 510(k) | Cleared | K260662 | Jun 4, 2026 | 94d | Oct 5, 2026 |
M Masimo Corporation |
Radius VSM and Accessories | Cardiovascular | 510(k) | Cleared | K254209 | Jun 4, 2026 | 157d | Oct 5, 2026 |
S Stryker Endoscopy |
Precision S 4K Sinuscope | Neurology | 510(k) | Cleared | K253602 | Jun 4, 2026 | 198d | Oct 5, 2026 |
R Resmed Corp |
Orion | Anesthesiology | 510(k) | Cleared | K253553 | Jun 4, 2026 | 202d | Oct 5, 2026 |
O Orthosoft Inc. (d/b/a) Zimmer CAS |
Signature ONE System | Orthopedic | 510(k) | Cleared | K261510 | Jun 4, 2026 | 28d | Oct 5, 2026 |
S Sonio |
Sonio Suspect | Imaging | 510(k) | Cleared | K261519 | Jun 4, 2026 | 28d | Oct 5, 2026 |
L Lap GmbH Laser Applikationen |
Luna 3D | Imaging | 510(k) | Cleared | K253004 | Jun 4, 2026 | 258d | Oct 5, 2026 |
S Smith and Nephew, Inc. |
Agili-C | Orthopedic | PMA Supplement | Approved | P210034/S001 | Jun 4, 2026 | 175d | Oct 5, 2026 |
B Boston Scientific Corporation |
TheraSphere Y-90 Glass Microspheres System | Imaging | PMA Supplement | Approved (30-day notice) | P200029/S013 | Jun 4, 2026 | 23d | Oct 5, 2026 |
A Alcon Research, LLC |
Hydrus® Microstent | Ophthalmic | PMA Supplement | Approved (30-day notice) | P170034/S018 | Jun 4, 2026 | 28d | Oct 5, 2026 |
L Leica Biosystems |
BOND Oracle HER2 IHC System | Diagnostics | PMA Supplement | Approved (30-day notice) | P090015/S014 | Jun 4, 2026 | 27d | Oct 5, 2026 |
M Medtronic Neuromodulation |
InterStim TM Therapy System; Verify Evaluation System; InterStim SNS Bowel Lead Model 978B1 | Other | PMA Supplement | Approved (30-day notice) | P080025/S346 | Jun 4, 2026 | 29d | Oct 5, 2026 |
I Integra Lifesciences Corp. |
CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | Dental | PMA Supplement | Approved (30-day notice) | P840062/S098 | Jun 4, 2026 | 27d | Oct 5, 2026 |
I Integra LifeSciences Corporation |
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent … | Surgical | PMA Supplement | Approved (30-day notice) | P850010/S118 | Jun 4, 2026 | 27d | Oct 5, 2026 |
N Novocure, GmbH |
Optune Gio | Neurology | PMA Supplement | Approved | P100034/S042 | Jun 4, 2026 | 247d | Oct 5, 2026 |
M Medtronic, Inc. |
Micra Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01 … | Cardiovascular | PMA Supplement | Approved | P150033/S224 | Jun 4, 2026 | 90d | Oct 5, 2026 |
M Medtronic Neuromodulation |
InterStim Therapy System; Verify Evaluation System; InterStim SNS Urinary Lead Model 978B1 | Other | PMA Supplement | Approved (30-day notice) | P970004/S451 | Jun 4, 2026 | 29d | Oct 5, 2026 |
I Integra LifeSciences Corporation |
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent … | Surgical | PMA Supplement | Approved (30-day notice) | P810006/S114 | Jun 4, 2026 | 27d | Oct 5, 2026 |
E Edwards Lifesciences, LLC |
Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent | Cardiovascular | PMA Supplement | Approved | P200015/S076 | Jun 4, 2026 | 87d | Oct 5, 2026 |
W Wave Neuroscience |
MeRT System | Neurology | 510(k) | Cleared | K260402 | Jun 3, 2026 | 117d | Oct 5, 2026 |
D Deka Research and Development |
iiSure Infusion Set | General Hospital | 510(k) | Cleared | K261530 | Jun 3, 2026 | 26d | Oct 5, 2026 |
S S&S Glove Corporation |
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl … | General Hospital | 510(k) | Cleared | K260703 | Jun 3, 2026 | 91d | Oct 5, 2026 |
C Case Medical, Inc. |
SteriTite Container System with MediTray Products | General Hospital | 510(k) | Cleared | K252854 | Jun 3, 2026 | 268d | Oct 5, 2026 |
Y Yurob Rehabilitation Medical Co., Ltd. |
Scooter (YD-03) | Physical Medicine | 510(k) | Cleared | K253600 | Jun 3, 2026 | 197d | Oct 5, 2026 |
T Tas Medical, Inc. |
Tissue Approximation System | Surgical | 510(k) | Cleared | K261484 | Jun 3, 2026 | 29d | Oct 5, 2026 |
A American Orthodontics |
BracePaste Prime Plus | Dental | 510(k) | Cleared | K261840 | Jun 3, 2026 | 1d | Oct 5, 2026 |
V Vista Industries,, LLC |
Nitrile Disposable Examination Gloves | General Hospital | 510(k) | Cleared | K260806 | Jun 3, 2026 | 83d | Oct 5, 2026 |
B Biowave Corporation |
BioWave BioWraps | Neurology | 510(k) | Cleared | K261522 | Jun 3, 2026 | 27d | Oct 5, 2026 |
I Institut Straumann AG |
Straumann® ProClean Cassette (041.800 ; 041.801) | General Hospital | 510(k) | Cleared | K260726 | Jun 3, 2026 | 90d | Oct 5, 2026 |
T Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. |
VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Neurology | 510(k) | Cleared | K260179 | Jun 3, 2026 | 133d | Oct 5, 2026 |
R Roosin Medical Co., Ltd. |
Roosin Collagen Powder | Other | 510(k) | Cleared | K254034 | Jun 3, 2026 | 169d | Oct 5, 2026 |
J Jiangsu Yveelt Medical Equipment Co., Ltd. |
Electric Wheelchair (DF506) | Physical Medicine | 510(k) | Cleared | K260373 | Jun 3, 2026 | 118d | Oct 5, 2026 |
K Karl Storz SE & CO. KG |
KARL STORZ Endoscopic Accessories for Urology | Other | 510(k) | Cleared | K252800 | Jun 3, 2026 | 273d | Oct 5, 2026 |
R Roosin Medical Co., Ltd. |
Roosin Collagen Dressing | Other | 510(k) | Cleared | K253974 | Jun 3, 2026 | 174d | Oct 5, 2026 |
T The Beauty Tech Group, Ltd. |
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | Surgical | 510(k) | Cleared | K260715 | Jun 3, 2026 | 90d | Oct 5, 2026 |
O Orthocon, Inc. |
Permatage Flowable, Settable Hemostatic Bone Paste | Other | 510(k) | Cleared | K261439 | Jun 3, 2026 | 34d | Oct 5, 2026 |
3 3D Systems, Inc. |
VSP System (Titanium Palatal Splint) | Dental | 510(k) | Cleared | K261826 | Jun 3, 2026 | 2d | Oct 5, 2026 |
D Deski |
HeartFocus | Imaging | 510(k) | Cleared | K260780 | Jun 3, 2026 | 85d | Oct 5, 2026 |
S Shenzhen Ziqing Medical Equipment Co., Ltd. |
Upper arm electronic blood pressure monitor (XB-01) | Cardiovascular | 510(k) | Cleared | K253124 | Jun 3, 2026 | 251d | Oct 5, 2026 |
C CustoMED , Ltd. |
CustoMED Viewer | Imaging | 510(k) | Cleared | K260116 | Jun 3, 2026 | 140d | Oct 5, 2026 |
S Sic Invent AG |
SIC Abutments including CAD/CAM Solutions | Dental | 510(k) | Cleared | K252904 | Jun 3, 2026 | 265d | Oct 5, 2026 |
E Edwards Lifesciences, LLC |
INSPIRIS RESILIA Aortic Valve | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150048/S101 | Jun 3, 2026 | 5d | Oct 5, 2026 |
B Boston Scientific Corp |
Altrua 2, Essentio, Proponent, Accolade | Cardiovascular | PMA Supplement | Approved (30-day notice) | N970003/S308 | Jun 3, 2026 | 30d | Oct 5, 2026 |
J Johnson & Johnson Surgical Vision, Inc. |
TECNIS 3-Piece Multifocal, Model ZMA00 | Ophthalmic | PMA Supplement | Approved (30-day notice) | P080010/S031 | Jun 3, 2026 | 26d | Oct 5, 2026 |
B Boston Scientific Corp |
Momentum, Momentum X4, Inogen, Dynagen, Vigilant, Vigilant X4, Resonate, Resonate X4, Resonate Hf | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010012/S609 | Jun 3, 2026 | 30d | Oct 5, 2026 |
B Boston Scientific Corporation |
Emblem, Emblem Mri | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110042/S212 | Jun 3, 2026 | 30d | Oct 5, 2026 |
E Endologix, LLC |
Alto Abdominal Stent Graft System | Cardiovascular | PMA Supplement | Approved | P120006/S045 | Jun 3, 2026 | 268d | Oct 5, 2026 |
D Depuy, Inc. |
LCS® Total Knee System | Orthopedic | PMA Supplement | Approved (30-day notice) | P830055/S366 | Jun 3, 2026 | 28d | Oct 5, 2026 |
B Boston Scientific |
Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741 … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150012/S186 | Jun 3, 2026 | 29d | Oct 5, 2026 |
B Boston Scientific |
Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P910073/S191 | Jun 3, 2026 | 29d | Oct 5, 2026 |
A Abbott Medical |
Navitor TAVI System with Vision Technology | Cardiovascular | PMA Supplement | Approved | P190023/S029 | Jun 3, 2026 | 180d | Oct 5, 2026 |
P Proverum, Ltd. |
ProVee System for BPH | Other | PMA Supplement | Approved (30-day notice) | P250011/S002 | Jun 3, 2026 | 28d | Oct 5, 2026 |
E Edwards Lifesciences, LLC |
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis | Cardiovascular | PMA Supplement | Approved (30-day notice) | P860057/S226 | Jun 3, 2026 | 5d | Oct 5, 2026 |
B Boston Scientific |
Inogen, Dynagen, Momentum, Vigilant El, Perciva Mini, Resonate El, Perciva Hf, Resonate Hf | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960040/S514 | Jun 3, 2026 | 30d | Oct 5, 2026 |
B Boston Scientific Corp |
EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672 … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010012/S610 | Jun 3, 2026 | 29d | Oct 5, 2026 |
J Johnson & Johnson Surgical Vision, Inc. |
TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 | Ophthalmic | PMA Supplement | Approved (30-day notice) | P990080/S066 | Jun 3, 2026 | 26d | Oct 5, 2026 |
B Boston Scientific |
ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480 | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960004/S116 | Jun 3, 2026 | 29d | Oct 5, 2026 |
B Boston Scientific Corporation |
S-ICD Electrode Model: 3501 | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110042/S213 | Jun 3, 2026 | 29d | Oct 5, 2026 |
E Envoy Medical Corporation |
Esteem® | Other | PMA Supplement | Approved (30-day notice) | P090018/S043 | Jun 3, 2026 | 30d | Oct 5, 2026 |
D DePuy Orthopaedics, Inc. |
Ceramax Ceramic Hip System | Orthopedic | PMA Supplement | Approved (30-day notice) | P070026/S127 | Jun 3, 2026 | 28d | Oct 5, 2026 |
B Boston Scientific |
Essentio Mri, Proponent Mri, Accolade Mri | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150012/S185 | Jun 3, 2026 | 30d | Oct 5, 2026 |
E Edwards Lifesciences, LLC |
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140031/S204 | Jun 3, 2026 | 5d | Oct 5, 2026 |
G Guidant Corp. |
Valitude, Valitude X4, Visionist, Visionist X4 | Cardiovascular | PMA Supplement | Approved (30-day notice) | P030005/S254 | Jun 3, 2026 | 30d | Oct 5, 2026 |
J Johnson & Johnson Surgical Vision, Inc. |
SENSAR 3-Piece Monofocal IOL, Models, AR40e, AR40E, AR40M, AR40MN | Ophthalmic | PMA Supplement | Approved (30-day notice) | P980040/S183 | Jun 3, 2026 | 26d | Oct 5, 2026 |
L Life Spine, Inc. |
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Neurology | 510(k) | Cleared | K260571 | Jun 2, 2026 | 103d | Oct 5, 2026 |
Z Zhejiang Kindly Medical Device Co., Ltd. |
Female Culture Device; Male Culture Device; Transfer Device; Access Device | Diagnostics | 510(k) | Cleared | K252899 | Jun 2, 2026 | 264d | Oct 5, 2026 |
C Carbon, Inc. |
DB 4000 High Impact Denture Base | Dental | 510(k) | Cleared | K260569 | Jun 2, 2026 | 103d | Oct 5, 2026 |
D DiaDent Group International |
Diafil | Dental | 510(k) | Cleared | K261093 | Jun 2, 2026 | 61d | Oct 5, 2026 |
O Orthalign, Inc. |
Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Neurology | 510(k) | Cleared | K253507 | Jun 2, 2026 | 211d | Oct 5, 2026 |
Z ZheJiang Decans Medical Devices Co., Ltd. |
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | Orthopedic | 510(k) | Cleared | K253195 | Jun 2, 2026 | 249d | Oct 5, 2026 |
B Biomet Microfixation |
Pectus Blu System | Orthopedic | 510(k) | Cleared | K261002 | Jun 2, 2026 | 68d | Oct 5, 2026 |
T Taiwan Surgical Corporation |
Inno-Port Disposable Bladed Trocar | Other | 510(k) | Cleared | K252532 | Jun 2, 2026 | 294d | Oct 5, 2026 |
W Wilson-Cook Medical, Inc. |
Hemospray Endoscopic Hemostat (HEMO-[X]) | Surgical | 510(k) | Cleared | K253302 | Jun 2, 2026 | 246d | Oct 5, 2026 |
F FindAir Sp. z o.o. |
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | Anesthesiology | 510(k) | Cleared | K260270 | Jun 2, 2026 | 125d | Oct 5, 2026 |
M Mohammadali Nezakati |
High Tone Power therapy (HiToP) (Model: HiToP PNP) | Physical Medicine | 510(k) | Cleared | K252816 | Jun 2, 2026 | 271d | Oct 5, 2026 |
T Tyto Care , Ltd. |
Tyto Insights for Wheeze Detection (with PCCP) | Anesthesiology | 510(k) | Cleared | K252844 | Jun 2, 2026 | 267d | Oct 5, 2026 |
L Lumenis Be, Ltd. |
MILAN System | Surgical | 510(k) | Cleared | K253803 | Jun 2, 2026 | 186d | Oct 5, 2026 |
A Anhui Longway Medical Technology Co., Ltd. |
Manual Wheelchair (LW01108) | Physical Medicine | 510(k) | Cleared | K260642 | Jun 2, 2026 | 95d | Oct 5, 2026 |
F F Care Systems USA, LLC |
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | Surgical | 510(k) | Cleared | K253918 | Jun 2, 2026 | 176d | Oct 5, 2026 |
G Geistlich Pharma AG |
Device 300419 Strip | Orthopedic | 510(k) | Cleared | K260364 | Jun 2, 2026 | 118d | Oct 5, 2026 |
F Fiagon GmbH |
Cube 4D Navigation System, VirtuEye Pro | Neurology | 510(k) | Cleared | K261540 | Jun 2, 2026 | 25d | Oct 5, 2026 |
E Exact Sciences Corporation |
Cologuard Plus | Diagnostics | PMA Supplement | Approved | P230043/S007 | Jun 2, 2026 | 88d | Oct 5, 2026 |
C Coloplast Corp. |
Titan Inflatable Penile Prosthesis (IPP) | Other | PMA Supplement | Approved | P000006/S072 | Jun 2, 2026 | 214d | Oct 5, 2026 |
C CorDx, Inc. |
CorDx Tyfast COVID-19 Ag Rapid Test Rx | Diagnostics | 510(k) | Cleared | K253882 | Jun 1, 2026 | 179d | Oct 5, 2026 |
T Traferox Technologies, Inc. |
VI°Port Liver Preservation System | Other | 510(k) | Cleared | K260456 | Jun 1, 2026 | 110d | Oct 5, 2026 |
V VisionAir Solutions |
VisionAir Enhanced Stock Stent | Surgical | 510(k) | Cleared | K261541 | Jun 1, 2026 | 24d | Oct 5, 2026 |
A Abbott Medical |
CardioMEMS HF System | Cardiovascular | PMA Supplement | Approved | P100045/S090 | Jun 1, 2026 | 42d | Oct 5, 2026 |
M Medtronic, Inc. |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130021/S186 | Jun 1, 2026 | 26d | Oct 5, 2026 |
B Boston Scientific |
INGEVITYTM+ Lead Passive Models | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150012/S187 | Jun 1, 2026 | 24d | Oct 5, 2026 |
M Medtronic, Inc. |
Avalus Bioprosthesis, Model 400 | Cardiovascular | PMA Supplement | Approved (30-day notice) | P170006/S044 | Jun 1, 2026 | 26d | Oct 5, 2026 |
M Medtronic, Inc. |
Harmony Transcatheter Pulmonary Valve | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200046/S051 | Jun 1, 2026 | 26d | Oct 5, 2026 |
M Medtronic, Inc. |
Melody Transcatheter Pulmonary Valve | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140017/S036 | Jun 1, 2026 | 26d | Oct 5, 2026 |
I In2Bones USA, LLC |
CoLink® & CoLag® Non-Sterile Screws | Orthopedic | 510(k) | Cleared | K261154 | May 30, 2026 | 52d | Sep 28, 2026 |
G Global Instrumentation, LLC |
M12 Telemetry System | Cardiovascular | 510(k) | Cleared | K252840 | May 29, 2026 | 266d | Sep 28, 2026 |
S Shenzhen Bi-Rich Medical Devices Co., Ltd. |
Peak Flow Meter (PF-10(BR-PEF231)) | Anesthesiology | 510(k) | Cleared | K252802 | May 29, 2026 | 268d | Sep 28, 2026 |
I INTEROJO, Inc. |
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | Ophthalmic | 510(k) | Cleared | K260507 | May 29, 2026 | 101d | Sep 28, 2026 |
O OrthoGrid Systems, Inc. |
OrthoGrid Hip AI® 4.0 | Imaging | 510(k) | Cleared | K260077 | May 29, 2026 | 137d | Sep 28, 2026 |
C Cosmo Artificial Intelligence - Ai, Ltd. |
GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Other | 510(k) | Cleared | K261369 | May 29, 2026 | 32d | Sep 28, 2026 |
M Mirco-Tech (Nanjing) Co., Ltd. |
Injection Needle | Other | 510(k) | Cleared | K260262 | May 29, 2026 | 121d | Sep 28, 2026 |
C Capnia, Inc. |
CoSense ETCO Monitor | Anesthesiology | 510(k) | Cleared | K253119 | May 29, 2026 | 247d | Sep 28, 2026 |
V Varex Imaging Corporation |
Nexus DRF Digital X-ray Imaging System | Imaging | 510(k) | Cleared | K253103 | May 29, 2026 | 247d | Sep 28, 2026 |
I iRhythm Technologies, Inc. |
ZEUS Platform (FG0501US) | Cardiovascular | 510(k) | Cleared | K252859 | May 29, 2026 | 262d | Sep 28, 2026 |
E Eufoton S.R.L. |
LASEmaR 1500 | Surgical | 510(k) | Cleared | K260489 | May 29, 2026 | 105d | Sep 28, 2026 |
N Newclip Technics |
Xpert PFP | Orthopedic | 510(k) | Cleared | K261038 | May 29, 2026 | 60d | Sep 28, 2026 |
C C.R. Bard, Inc. |
BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | Other | 510(k) | Cleared | K254076 | May 29, 2026 | 162d | Sep 28, 2026 |
S Spine Wave, Inc. |
Exceed® Biplanar Expandable Interbody System | Orthopedic | 510(k) | Cleared | K261159 | May 29, 2026 | 51d | Sep 28, 2026 |
E Entire Medical , Ltd. |
ENTire IRE System | Surgical | 510(k) | Cleared | K261202 | May 29, 2026 | 46d | Sep 28, 2026 |
H HistoSonics, Inc. |
HistoSonics® Planning Tool | Imaging | 510(k) | Cleared | K252947 | May 29, 2026 | 256d | Sep 28, 2026 |
O Oxytek Medical Technology Co., Ltd. |
Oxygen Concentrator (OX-5A, OX-5C) | Anesthesiology | 510(k) | Cleared | K252965 | May 29, 2026 | 254d | Sep 28, 2026 |
P Philips Medizin Systeme Böblingen GmbH |
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Cardiovascular | 510(k) | Cleared | K252821 | May 29, 2026 | 267d | Sep 28, 2026 |
A Avanutri Equipamentos DE Saúde |
Cryo Sport 2.0 (AVA 501) | Physical Medicine | 510(k) | Cleared | K252396 | May 29, 2026 | 302d | Sep 28, 2026 |
A Anker Innovations Limited |
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Women's Health | 510(k) | Cleared | K254300 | May 29, 2026 | 149d | Sep 28, 2026 |
E Enamel Pure |
LUNE PureHygiene | Surgical | 510(k) | Cleared | K260138 | May 29, 2026 | 133d | Sep 28, 2026 |
T Tyber Medical, LLC |
Navigated LLIF Impactable Tracker | Neurology | 510(k) | Cleared | K261060 | May 29, 2026 | 59d | Sep 28, 2026 |
A Abbott Medical |
Aveir VR (LSCD111); DR Delivery Catheter (LSCD201) | Cardiovascular | PMA Supplement | Approved | P150035/S038 | May 29, 2026 | 88d | Sep 28, 2026 |
A Abbott Medical |
HeartMate 3 Left Ventricular Assist System | Cardiovascular | PMA Supplement | Approved | P160054/S121 | May 29, 2026 | 109d | Sep 28, 2026 |
M Medtronic Vascular |
Resolute Onyx Zotarolimus-Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160043/S093 | May 29, 2026 | 28d | Sep 28, 2026 |
B Boston Scientific Corporation |
POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths … | Cardiovascular | PMA Supplement | Approved | P220032/S012 | May 29, 2026 | 28d | Sep 28, 2026 |
A Abbott Medical |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P220013/S032 | May 29, 2026 | 28d | Sep 28, 2026 |
A Abbott Medical |
HeartMate II Left Ventricular Assist System | Cardiovascular | PMA Supplement | Approved | P060040/S123 | May 29, 2026 | 109d | Sep 28, 2026 |
A Alcon Laboratories, Inc. |
Focus Night And Day (Lotrafilcon A) Soft Contact Lenses | Ophthalmic | PMA Supplement | Approved (30-day notice) | P010019/S087 | May 29, 2026 | 25d | Sep 28, 2026 |
P Premia Spine, Ltd. |
TOPS System | Orthopedic | PMA Supplement | Approved | P220002/S009 | May 29, 2026 | 284d | Sep 28, 2026 |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved (30-day notice) | P180046/S111 | May 29, 2026 | 28d | Sep 28, 2026 |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved (30-day notice) | P190006/S111 | May 29, 2026 | 28d | Sep 28, 2026 |
S St Jude Medical |
TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130026/S101 | May 29, 2026 | 28d | Sep 28, 2026 |
D Dukal, LLC |
Dukal Crepe Paper Sterilization Wrap | General Hospital | 510(k) | Cleared | K252823 | May 28, 2026 | 266d | Sep 28, 2026 |
B Bioptimal International Pte. , Ltd. |
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF … | Cardiovascular | 510(k) | Cleared | K252702 | May 28, 2026 | 274d | Sep 28, 2026 |
V Vieworks Co., Ltd. |
Bellalun 2D (VDMS-1000S) | Imaging | 510(k) | Cleared | K254092 | May 28, 2026 | 160d | Sep 28, 2026 |
M Medtronic |
Trexon Monofilament Synthetic Absorbable Suture | Surgical | 510(k) | Cleared | K253530 | May 28, 2026 | 196d | Sep 28, 2026 |
M Motion Composites |
Helio Kids; Apex P | Physical Medicine | 510(k) | Cleared | K260295 | May 28, 2026 | 119d | Sep 28, 2026 |
A Arthrex, Inc. |
Arthrex Bioabsorbable PushLock Suture Anchors | Orthopedic | 510(k) | Cleared | K253931 | May 28, 2026 | 170d | Sep 28, 2026 |
S Stryker Endoscopy |
780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Imaging | 510(k) | Cleared | K261037 | May 28, 2026 | 59d | Sep 28, 2026 |
B BD Diagnostic Systems |
BD BACTEC FXI Culture System | Diagnostics | 510(k) | Cleared | K260213 | May 28, 2026 | 125d | Sep 28, 2026 |
Z Zimmer, Inc. |
Zimmer® Persona® Personalized Knee System | Orthopedic | 510(k) | Cleared | K251840 | May 28, 2026 | 346d | Sep 28, 2026 |
I Imeka Solutions, Inc. |
Andi 2.2 | Imaging | 510(k) | Cleared | K261405 | May 28, 2026 | 29d | Sep 28, 2026 |
Y Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Disposable Endoscopic Distal Attachments | Other | 510(k) | Cleared | K260423 | May 28, 2026 | 108d | Sep 28, 2026 |
G Global Biomedica s.r.o. |
BMD Titanium Spinal Fusion System | Orthopedic | 510(k) | Cleared | K253894 | May 28, 2026 | 175d | Sep 28, 2026 |
A Algiamed Technologies USA, Inc. |
STIMPOD NMS460 Nerve Stimulator | Neurology | 510(k) | Cleared | K252712 | May 28, 2026 | 274d | Sep 28, 2026 |
G Guangxi Ulike Medical Technology Co., Ltd. |
Ulike Clear Zero (YC10 BU) | Neurology | 510(k) | Cleared | K260895 | May 28, 2026 | 71d | Sep 28, 2026 |
M Medtronic, Inc. |
Affera Ablation System | Cardiovascular | PMA Supplement | Approved | P240013/S022 | May 28, 2026 | 90d | Sep 28, 2026 |
M Medtronic, Inc. |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) Balloon Catheter | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140010/S105 | May 28, 2026 | 27d | Sep 28, 2026 |
A Abbott Medical |
TriClip Delivery System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230007/S022 | May 28, 2026 | 29d | Sep 28, 2026 |
A Abbott Medical |
AmplatzerTM PFO Occluder; AmplatzerTM Talisman PFO Occluder | Cardiovascular | PMA Supplement | Approved (30-day notice) | P120021/S028 | May 28, 2026 | 29d | Sep 28, 2026 |
A Abbott Medical |
AmplatzerTM Septal Occluder; AmplatzerTM Multifenestrated Septal Occluder - Cribriform | Cardiovascular | PMA Supplement | Approved (30-day notice) | P000039/S084 | May 28, 2026 | 29d | Sep 28, 2026 |
A Abbott Medical |
AmplatzerTM Muscular VSD Occluder | Cardiovascular | PMA Supplement | Approved (30-day notice) | P040040/S051 | May 28, 2026 | 29d | Sep 28, 2026 |
A Abbott Medical |
AmplatzerTM Duct Occluder | Cardiovascular | PMA Supplement | Approved (30-day notice) | P020024/S073 | May 28, 2026 | 29d | Sep 28, 2026 |
A Alcon Research, LLC |
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Ophthalmic | PMA Supplement | Approved (30-day notice) | P220030/S011 | May 28, 2026 | 23d | Sep 28, 2026 |
T Tempus AI, Inc. |
xT CDx | Diagnostics | PMA Supplement | Approved | P210011/S004 | May 28, 2026 | 332d | Sep 28, 2026 |
A Abbott Molecular, Inc. |
Abbott RealTime IDH2 | Other | PMA Supplement | Approved (30-day notice) | P170005/S006 | May 28, 2026 | 23d | Sep 28, 2026 |
A Abbott Molecular, Inc. |
Abbott RealTime IDH1 | Other | PMA Supplement | Approved (30-day notice) | P170041/S009 | May 28, 2026 | 23d | Sep 28, 2026 |
A Abbott Medical |
AmplatzerTM Amulet Left Atrial Appendage Occluder | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200049/S018 | May 28, 2026 | 29d | Sep 28, 2026 |
A Abbott Medical |
TactiFlex Sensor Enabled Ablation Catheter | Cardiovascular | PMA Supplement | Approved | P220013/S022 | May 28, 2026 | 253d | Sep 28, 2026 |
B Biotronik, Inc. |
Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53 … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P950037/S293 | May 28, 2026 | 28d | Sep 28, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
SelectSecure Lead Model 3830 | Cardiovascular | PMA Supplement | Approved | P030036/S158 | May 28, 2026 | 90d | Sep 28, 2026 |
A Alcon Research, LLC |
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Ophthalmic | PMA Supplement | Approved (30-day notice) | P230012/S011 | May 28, 2026 | 23d | Sep 28, 2026 |
A Abbott Medical |
MitraClip Delivery Systems | Cardiovascular | PMA Supplement | Approved (30-day notice) | P100009/S085 | May 28, 2026 | 29d | Sep 28, 2026 |
I Inspire Medical Systems |
Inspire Model 4063 Leads; Inspire Model 4340 Leads | Anesthesiology | PMA Supplement | Approved (30-day notice) | P130008/S139 | May 28, 2026 | 29d | Sep 28, 2026 |
C Caris Life Sciences |
MI Cancer Seek® | Other | PMA Supplement | Approved (30-day notice) | P240010/S009 | May 28, 2026 | 28d | Sep 28, 2026 |
N NeuroPace, Inc. |
NeuroPace® RNS® System | Neurology | PMA Supplement | Approved | P100026/S101 | May 28, 2026 | 295d | Sep 28, 2026 |
M MicroVention, Inc. |
Woven EndoBridge (WEB) Aneurysm Embolization System | Neurology | PMA Supplement | Approved (30-day notice) | P170032/S022 | May 28, 2026 | 23d | Sep 28, 2026 |
B Boston Scientific Corp |
Deep Brain Stimulation (DBS) Systems | Neurology | PMA Supplement | Approved | P150031/S092 | May 28, 2026 | 87d | Sep 28, 2026 |
B Boston Scientific Corp |
Spinal Cord Stimulation (SCS) | Neurology | PMA Supplement | Approved | P030017/S393 | May 28, 2026 | 87d | Sep 28, 2026 |
A Abbott Molecular, Inc. |
Alinity m HR HPV | Diagnostics | PMA Supplement | Approved (30-day notice) | P230003/S017 | May 28, 2026 | 23d | Sep 28, 2026 |
R Resmed Corp |
ResScan Essentials | Anesthesiology | 510(k) | Cleared | K254104 | May 27, 2026 | 159d | Sep 28, 2026 |
Z ZheJiang Decans Medical Devices Co., Ltd. |
Dione PEEK Screw System | Orthopedic | 510(k) | Cleared | K253130 | May 27, 2026 | 244d | Sep 28, 2026 |
Z ZheJiang Decans Medical Devices Co., Ltd. |
AQUA Laminoplasty Systems | Orthopedic | 510(k) | Cleared | K252930 | May 27, 2026 | 254d | Sep 28, 2026 |
F Fujifilm Corporation |
Synapse Lung Nodule AI | Imaging | 510(k) | Cleared | K254075 | May 27, 2026 | 160d | Sep 28, 2026 |
P Philips Ultrasound, LLC |
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Imaging | 510(k) | Cleared | K260680 | May 27, 2026 | 86d | Sep 28, 2026 |
M Motion Informatics ltd. |
StimelMD (SSMD) system | Physical Medicine | 510(k) | Cleared | K260142 | May 27, 2026 | 127d | Sep 28, 2026 |
M Medicrea International S.A.S |
LigaPASS System | Orthopedic | 510(k) | Cleared | K261374 | May 27, 2026 | 30d | Sep 28, 2026 |
S Sysmex America, Inc. |
XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Diagnostics | 510(k) | Cleared | K253212 | May 27, 2026 | 240d | Sep 28, 2026 |
P Philips Medical Systems Nederland B.V. |
Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Imaging | 510(k) | Cleared | K260207 | May 27, 2026 | 124d | Sep 28, 2026 |
V Visby Medical, Inc. |
Visby Medical Flu and COVID-19 Test | Diagnostics | 510(k) | Cleared | K253971 | May 27, 2026 | 167d | Sep 28, 2026 |
V Videomed Srl ( a Baxter Healthcare Corp company) |
Helion Viewer Suite | Imaging | 510(k) | Cleared | K254265 | May 27, 2026 | 148d | Sep 28, 2026 |
P PDX Co., Ltd. |
Portable Dental X-ray System Model PDX nova | Dental | 510(k) | Cleared | K260367 | May 27, 2026 | 112d | Sep 28, 2026 |
S Smith & Nephew Medical, Ltd. |
Renasys Edge (66803126) | Surgical | 510(k) | Cleared | K260646 | May 27, 2026 | 89d | Sep 28, 2026 |
G Glytec, LLC |
Glucommander | Anesthesiology | 510(k) | Cleared | K254102 | May 27, 2026 | 159d | Sep 28, 2026 |
P Philips Ultrasound, LLC |
EPIQ Series Diagnostic Ultrasound System | Imaging | 510(k) | Cleared | K260123 | May 27, 2026 | 132d | Sep 28, 2026 |
E Exact Sciences Corporation |
Cologuard® | Diagnostics | PMA Supplement | Approved | P130017/S068 | May 27, 2026 | 83d | Sep 28, 2026 |
I Integra LifeSciences Corporation |
Helistat® Absorbable Collagen Hemostatic Agent | Surgical | PMA Supplement | Approved (30-day notice) | P850010/S117 | May 27, 2026 | 30d | Sep 28, 2026 |
I Integra LifeSciences Corporation |
Collastat Absorbable Collagen Hemostatic Sponge | Surgical | PMA Supplement | Approved (30-day notice) | P810006/S113 | May 27, 2026 | 30d | Sep 28, 2026 |
F Foundation Medicine, Inc. |
FoundationOne CDx (F1CDx) | Diagnostics | PMA Supplement | Approved | P170019/S062 | May 27, 2026 | 551d | Sep 28, 2026 |
F Foundation Medicine, Inc. |
FoundationOne CDx (F1CDx) | Diagnostics | PMA Supplement | Approved | P170019/S060 | May 27, 2026 | 614d | Sep 28, 2026 |
F Foundation Medicine, Inc. |
FoundationOne CDx (F1CDx) | Diagnostics | PMA Supplement | Approved | P170019/S057 | May 27, 2026 | 663d | Sep 28, 2026 |
F Foundation Medicine, Inc. |
FoundationOne CDx | Diagnostics | PMA Supplement | Approved | P170019/S065 | May 27, 2026 | 476d | Sep 28, 2026 |
C Contego Medical, Inc. |
Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240009/S011 | May 27, 2026 | 29d | Sep 28, 2026 |
F Foundation Medicine, Inc. |
FoundationOne Liquid CDx | Diagnostics | PMA Supplement | Approved | P190032/S029 | May 27, 2026 | 490d | Sep 28, 2026 |
B Biomet Manufacturing Corp |
Oxford Partial Knee System; Cementless OxfordPartial Knee System | Orthopedic | PMA Supplement | Approved | P010014/S112 | May 27, 2026 | 183d | Sep 28, 2026 |
E Exact Sciences Corporation |
Cologuard Plus | Diagnostics | PMA Supplement | Approved | P230043/S006 | May 27, 2026 | 83d | Sep 28, 2026 |
I Integra Lifesciences Corp. |
CollaCote® and CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery | Dental | PMA Supplement | Approved (30-day notice) | P840062/S097 | May 27, 2026 | 30d | Sep 28, 2026 |
A Abbott Medical |
HeartMate 3 Left Ventricular Assist System | Cardiovascular | PMA Supplement | Approved | P160054/S122 | May 27, 2026 | 89d | Sep 28, 2026 |
S Starmed Co., Ltd. |
VIVA combo RF System | Surgical | 510(k) | Cleared | K252833 | May 26, 2026 | 263d | Sep 28, 2026 |
S Shenzhen Root Innovation Technology Co., Ltd. |
Momcozy Nasal Aspirator (BN007) | Surgical | 510(k) | Cleared | K253629 | May 26, 2026 | 188d | Sep 28, 2026 |
M Medos International SARL |
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Neurology | 510(k) | Cleared | K254157 | May 26, 2026 | 155d | Sep 28, 2026 |
S Sdip Innovations Pty, Ltd. |
JAZBI Resorbable Bone Void Filler | Orthopedic | 510(k) | Cleared | K252797 | May 26, 2026 | 265d | Sep 28, 2026 |
G GE Medical Systems Ultrasound and Primary Care Diagnostics |
LOGIQ e | Imaging | 510(k) | Cleared | K260398 | May 26, 2026 | 109d | Sep 28, 2026 |
Z Zhejiang Healnoc Technology Co., Ltd. |
4K NIR/ICG Imaging System | Other | 510(k) | Cleared | K260318 | May 26, 2026 | 116d | Sep 28, 2026 |
C Clarus Medical, LLC |
Digital ClarusScope System and Digital NeuroPEN System | Orthopedic | 510(k) | Cleared | K252790 | May 26, 2026 | 266d | Sep 28, 2026 |
E Edwards Lifesciences, LLC |
Edwards EVOQUE Tricuspid Valve Replacement System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230013/S030 | May 26, 2026 | 25d | Sep 28, 2026 |
W W. L. Gore & Associates, Inc. |
GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | Cardiovascular | PMA Supplement | Approved (30-day notice) | P040037/S172 | May 26, 2026 | 26d | Sep 28, 2026 |
C Cerenovus, Inc. |
TRUFILL n-BCA Liquid Embolic System | Neurology | PMA Supplement | Approved (30-day notice) | P990040/S038 | May 26, 2026 | 35d | Sep 28, 2026 |
W W. L. Gore & Associates, Inc. |
GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130006/S111 | May 26, 2026 | 26d | Sep 28, 2026 |
M Medtronic Minimed, Inc. |
Simplera and Simplera Sync | Diagnostics | PMA Supplement | Approved (30-day notice) | P160017/S137 | May 26, 2026 | 29d | Sep 28, 2026 |
M Medtronic Minimed, Inc. |
Simplera and Simplera Sync | Diagnostics | PMA Supplement | Approved (30-day notice) | P250012/S010 | May 26, 2026 | 29d | Sep 28, 2026 |
M Medtronic Minimed |
Simplera and Simplera Sync | Diagnostics | PMA Supplement | Approved (30-day notice) | P160007/S062 | May 26, 2026 | 29d | Sep 28, 2026 |
A Abbott Medical |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Neurology | PMA Supplement | Approved (30-day notice) | P010032/S252 | May 26, 2026 | 33d | Sep 28, 2026 |
E Edwards Lifesciences, LLC |
TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33 mm | Cardiovascular | PMA Supplement | Approved | P150048/S094 | May 26, 2026 | 189d | Sep 28, 2026 |
E Ev3 Neurovascular |
Apollo Onyx Delivery Micro Catheter | Neurology | PMA Supplement | Approved (30-day notice) | P030004/S043 | May 26, 2026 | 27d | Sep 28, 2026 |
C Carl Zeiss Meditec, Inc. |
VISUMAX 800 Femtosecond Laser | Ophthalmic | PMA Supplement | Approved | P150040/S024 | May 26, 2026 | 92d | Sep 28, 2026 |
D DiaSorin, Inc. |
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON … | Diagnostics | PMA Supplement | Approved (30-day notice) | P180047/S044 | May 26, 2026 | 28d | Sep 28, 2026 |
A Abbott Medical |
Navitor Transcatheter Aortic Valve Implantation System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P190023/S032 | May 26, 2026 | 29d | Sep 28, 2026 |
P Parallel Robotics, LLC |
MediBot Needle Driver Uno | Other | 510(k) | Cleared | K260183 | May 24, 2026 | 123d | Sep 28, 2026 |
A Ai Health Highway India Pvt., Ltd. |
AiSteth® | Cardiovascular | 510(k) | Cleared | K252915 | May 22, 2026 | 252d | Sep 21, 2026 |
M Merit Medical Ireland, Ltd. |
InQwire Amplatz Guide Wire | Cardiovascular | 510(k) | Cleared | K254137 | May 22, 2026 | 151d | Sep 21, 2026 |
V Vivachek Biotech (Hangzhou) Co., Ltd. |
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Other | 510(k) | Cleared | K261280 | May 22, 2026 | 35d | Sep 21, 2026 |
D DePuy Orthopaedics, Inc. |
DePuy ATTUNE Knee System | Orthopedic | 510(k) | Cleared | K252887 | May 22, 2026 | 254d | Sep 21, 2026 |
S Suzhou Zenith Vascular SciTech Limited |
Zenith Distal Access Long Sheath | Cardiovascular | 510(k) | Cleared | K253359 | May 22, 2026 | 234d | Sep 21, 2026 |
P Protect Gloves Company Limited |
Sterile Latex Powder Free Surgical Gloves | Surgical | 510(k) | Cleared | K253060 | May 22, 2026 | 242d | Sep 21, 2026 |
S SurGenTec, LLC |
Ion-C Navigation Instruments | Neurology | 510(k) | Cleared | K260329 | May 22, 2026 | 112d | Sep 21, 2026 |
P Pulmera, Inc. |
C-beam | Imaging | 510(k) | Cleared | K252735 | May 22, 2026 | 267d | Sep 21, 2026 |
I Intuitive Surgical |
da Vinci Firefly Imaging System | Other | 510(k) | Cleared | K260695 | May 22, 2026 | 80d | Sep 21, 2026 |
C Canon Medical Informatics, Inc. |
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Imaging | 510(k) | Cleared | K260324 | May 22, 2026 | 112d | Sep 21, 2026 |
C Cardiosense, Inc. |
PCWP Analysis Software | Cardiovascular | De Novo | Granted | DEN250057 | May 22, 2026 | 186d | Sep 21, 2026 |
T Tonica Elektronik A/S |
MagVenture Accelerated TMS (aTMS) Therapy System | Neurology | 510(k) | Cleared | K260189 | May 22, 2026 | 120d | Sep 21, 2026 |
G Genesee Biomedical, Inc. |
ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Surgical | 510(k) | Cleared | K252917 | May 22, 2026 | 252d | Sep 21, 2026 |
N Neko Health AB |
Spectrum-2 | Cardiovascular | 510(k) | Cleared | K254129 | May 22, 2026 | 151d | Sep 21, 2026 |
T Tz Medical, Inc. |
Arc Adjustable Radial Cuff Compression Device | Cardiovascular | 510(k) | Cleared | K252772 | May 22, 2026 | 262d | Sep 21, 2026 |
A Atmo Biosciences, Ltd. |
Atmo Gas Capsule System | Other | 510(k) | Cleared | K253569 | May 22, 2026 | 186d | Sep 21, 2026 |
S Shanghai United Imaging Healthcare Co., Ltd. |
uMR Astra | Imaging | 510(k) | Cleared | K260113 | May 22, 2026 | 128d | Sep 21, 2026 |
M Mag & More GmbH |
Apollo TMS Therapy System;Apollo light TMS Therapy System | Neurology | 510(k) | Cleared | K260560 | May 22, 2026 | 92d | Sep 21, 2026 |
C CHISON Medical Technologies Co., Ltd. |
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro … | Imaging | 510(k) | Cleared | K253949 | May 22, 2026 | 163d | Sep 21, 2026 |
T Taizhou Huangyan Guanhong Plastic Steel Products Factory |
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA) … | General Hospital | 510(k) | Cleared | K253773 | May 22, 2026 | 177d | Sep 21, 2026 |
A Anatomical Geometry S.L. |
eXaSkin Plus | Imaging | 510(k) | Cleared | K252784 | May 22, 2026 | 262d | Sep 21, 2026 |
S Senzime AB |
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric … | Anesthesiology | 510(k) | Cleared | K261098 | May 22, 2026 | 50d | Sep 21, 2026 |
M Medtronic Neuromodulation |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces … | Neurology | PMA Supplement | Approved (30-day notice) | P840001/S626 | May 22, 2026 | 30d | Sep 21, 2026 |
C Companion Spine France |
coflex® Interlaminar Technology | Orthopedic | PMA Supplement | Approved | P110008/S015 | May 22, 2026 | 28d | Sep 21, 2026 |
A Abbott Medical |
Esprit BTK Everolimus Eluting Resorbable Scaffold System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230036/S018 | May 22, 2026 | 29d | Sep 21, 2026 |
A Abbott Vascular, Inc. |
Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960043/S134 | May 22, 2026 | 28d | Sep 21, 2026 |
M Medtronic Neuromodulation |
InterStim Therapy System; Verify Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1) | Other | PMA Supplement | Approved (30-day notice) | P080025/S345 | May 22, 2026 | 28d | Sep 21, 2026 |
A Abbott Vascular |
XIENCE Alpine, XIENCE Sierra, XIENCE PRO S, and XIENCE Skypoint Everolimus Eluting Coronary Stent Systems | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110019/S141 | May 22, 2026 | 29d | Sep 21, 2026 |
M Medtronic Neuromodulation |
InterStim Therapy System; Verify Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1) | Other | PMA Supplement | Approved (30-day notice) | P970004/S450 | May 22, 2026 | 28d | Sep 21, 2026 |
M Medtronic Neuromodulation |
Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and … | Neurology | PMA Supplement | Approved (30-day notice) | P840001/S627 | May 22, 2026 | 28d | Sep 21, 2026 |
M Medtronic, Inc. |
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (3387S, 3389S, 3550-05, B31010) | Neurology | PMA Supplement | Approved (30-day notice) | P960009/S535 | May 22, 2026 | 28d | Sep 21, 2026 |
S Shenzhen Ulike Smart Electronics Co., Ltd. |
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Surgical | 510(k) | Cleared | K261325 | May 21, 2026 | 29d | Sep 21, 2026 |
B Boston Aesthetics, Inc. |
Boston 2910 (Boston 2910) | Surgical | 510(k) | Cleared | K253245 | May 21, 2026 | 234d | Sep 21, 2026 |
W Wuhan United Imaging Healthcare Co.,Ltd |
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Imaging | 510(k) | Cleared | K253720 | May 21, 2026 | 178d | Sep 21, 2026 |
C Cork Medical |
Nisus NPWT Canister 500-mL (CPC-500) | Surgical | 510(k) | Cleared | K261291 | May 21, 2026 | 31d | Sep 21, 2026 |
D Dental Creativ Management GmbH |
DCMhotbond zircon | Dental | 510(k) | Cleared | K253191 | May 21, 2026 | 237d | Sep 21, 2026 |
P PanopticAI Technologies Limited |
PanopticAI Vital Signs (1.6.1-22) | Cardiovascular | 510(k) | Cleared | K260066 | May 21, 2026 | 132d | Sep 21, 2026 |
O Olympus Medical Systems Corp. |
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135) … | Other | 510(k) | Cleared | K260580 | May 21, 2026 | 90d | Sep 21, 2026 |
S Sofradim Production |
ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Surgical | 510(k) | Cleared | K253956 | May 21, 2026 | 162d | Sep 21, 2026 |
G Guangdong Dayang Medical Technology Co., Ltd. |
Manual Wheelchair (DY01903(2)) | Physical Medicine | 510(k) | Cleared | K254141 | May 21, 2026 | 150d | Sep 21, 2026 |
S Shenzhen TPH Technology Co., Ltd. |
Wearable Breast Pump (Model S39) | Women's Health | 510(k) | Cleared | K254244 | May 21, 2026 | 143d | Sep 21, 2026 |
S Spectralmd, Inc. |
DeepView AI® System | Surgical | De Novo | Granted | DEN250028 | May 21, 2026 | 328d | Sep 21, 2026 |
O Olympus Winter & Ibe GmbH |
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO) … | Other | 510(k) | Cleared | K260649 | May 21, 2026 | 83d | Sep 21, 2026 |
U Ulthera, Inc. |
Ulthera® System | Surgical | 510(k) | Cleared | K260618 | May 21, 2026 | 85d | Sep 21, 2026 |
H Hlb Lifescience Co., Ltd. |
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle) … | General Hospital | 510(k) | Cleared | K253112 | May 21, 2026 | 239d | Sep 21, 2026 |
D Drägerwerk AG Co. Kgaa |
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Anesthesiology | 510(k) | Cleared | K252746 | May 21, 2026 | 265d | Sep 21, 2026 |
D Dexcom, Inc. |
Stelo Glucose Biosensor System | Diagnostics | 510(k) | Cleared | K261359 | May 21, 2026 | 27d | Sep 21, 2026 |
S Smart Alfa Teknoloji San. Ve Tic. A.S. |
MSK Go | Imaging | 510(k) | Cleared | K260234 | May 21, 2026 | 115d | Sep 21, 2026 |
D DeepHealth, Inc. |
BAC | Imaging | 510(k) | Cleared | K254131 | May 21, 2026 | 150d | Sep 21, 2026 |
O Orthosoft Inc. (d/b/a) Zimmer CAS |
ROSA® Shoulder System | Neurology | 510(k) | Cleared | K260582 | May 21, 2026 | 90d | Sep 21, 2026 |
D Dcstar, Inc. |
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Anesthesiology | 510(k) | Cleared | K251920 | May 21, 2026 | 332d | Sep 21, 2026 |
M MoleculeX Co., Ltd. |
MuCover (proposed name) Oral Wound Dressing | Other | 510(k) | Cleared | K253816 | May 21, 2026 | 174d | Sep 21, 2026 |
P Pegavision Corporation |
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses … | Ophthalmic | 510(k) | Cleared | K253352 | May 21, 2026 | 233d | Sep 21, 2026 |
T Taewoong Medical Co., Ltd. |
Sphincterotome | Other | 510(k) | Cleared | K260962 | May 21, 2026 | 59d | Sep 21, 2026 |
P Pjur Group Luxembourg S.A. |
pjur NATURE Touch, 100 ml | Women's Health | 510(k) | Cleared | K260068 | May 21, 2026 | 132d | Sep 21, 2026 |
S Siemens Medical Solutions USA, Inc. |
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753) … | Imaging | 510(k) | Cleared | K261315 | May 21, 2026 | 30d | Sep 21, 2026 |
W William Cook Europe Aps |
Zenith Fenestrated AAA Endovascular Graft | Cardiovascular | PMA Supplement | Approved (30-day notice) | P180001/S017 | May 21, 2026 | 28d | Sep 21, 2026 |
M Medtronic Vascular, Inc. |
IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Cardiovascular | PMA Supplement | Approved (30-day notice) | P190008/S049 | May 21, 2026 | 28d | Sep 21, 2026 |
C Cook Medical Incorporated |
Zenith Alpha Thoracic Endovascular Graft; Zenith Dissection Endovascular System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140016/S017 | May 21, 2026 | 28d | Sep 21, 2026 |
G Guardant Health, Inc. |
Shield | Other | PMA Supplement | Approved (30-day notice) | P230009/S016 | May 21, 2026 | 20d | Sep 21, 2026 |
P Philips Medical Systems |
HeartStart FRx Defibrillator (861304) | Cardiovascular | PMA Supplement | Approved | P180028/S019 | May 21, 2026 | 85d | Sep 21, 2026 |
O Organox Limited |
OrganOx metra® System | Other | PMA Supplement | Approved | P200035/S033 | May 21, 2026 | 142d | Sep 21, 2026 |
C Cook, Inc. |
Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P020018/S068 | May 21, 2026 | 28d | Sep 21, 2026 |
B Boston Scientific Corp |
Celestia Implantable Pulse Generator, Celestia External Trial Stimulator | Neurology | PMA Supplement | Approved | P030017/S392 | May 21, 2026 | 101d | Sep 21, 2026 |
E Envoy Medical Corporation |
Esteem® | Other | PMA Supplement | Approved | P090018/S042 | May 21, 2026 | 91d | Sep 21, 2026 |
P Philips Medical Systems, Inc. |
HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator | Cardiovascular | PMA Supplement | Approved | P160028/S007 | May 21, 2026 | 85d | Sep 21, 2026 |
M Medtronic, Inc. |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140010/S104 | May 21, 2026 | 28d | Sep 21, 2026 |
S Suzhou Zenith Vascular SciTech Limited |
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Cardiovascular | 510(k) | Cleared | K252707 | May 20, 2026 | 266d | Sep 21, 2026 |
L Lagis Enterprise Co., Ltd. |
LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Surgical | 510(k) | Cleared | K253134 | May 20, 2026 | 237d | Sep 21, 2026 |
N Neko Health AB |
Derma-2 | Women's Health | 510(k) | Cleared | K253911 | May 20, 2026 | 163d | Sep 21, 2026 |
C Canon Medical Systems Corporation |
Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Imaging | 510(k) | Cleared | K253596 | May 20, 2026 | 183d | Sep 21, 2026 |
C Circadia Health, Inc. |
The Circadia C300 System (C300) | Cardiovascular | 510(k) | Cleared | K261286 | May 20, 2026 | 30d | Sep 21, 2026 |
S Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
Mobility Scooter (Air Carbon) | Physical Medicine | 510(k) | Cleared | K260717 | May 20, 2026 | 76d | Sep 21, 2026 |
W WAVE Medical AG |
WAVE PTA Balloon Catheter | Cardiovascular | 510(k) | Cleared | K260304 | May 20, 2026 | 110d | Sep 21, 2026 |
S Shenzhen Xiazhifeng Electronic Co., Ltd. |
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG … | Surgical | 510(k) | Cleared | K260594 | May 20, 2026 | 86d | Sep 21, 2026 |
S Shenzhen Jamr Technology Co., Ltd. |
Blood Pressure Monitor (W06LT) | Cardiovascular | 510(k) | Cleared | K253570 | May 20, 2026 | 184d | Sep 21, 2026 |
S Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM … | Cardiovascular | 510(k) | Cleared | K260098 | May 20, 2026 | 127d | Sep 21, 2026 |
E Elos Medtech Pinol A/S |
Elos Accurate® Denture Fixation System | Dental | 510(k) | Cleared | K253774 | May 20, 2026 | 175d | Sep 21, 2026 |
V Varian Medical Systems |
MAASTRO Rectal Applicator Set | Imaging | 510(k) | Cleared | K252717 | May 20, 2026 | 265d | Sep 21, 2026 |
M MicroPort NeuroTech (Shanghai) Co., Ltd. |
Numen Helia Coil Embolization System; NumenFR Detachment System | Neurology | 510(k) | Cleared | K260351 | May 20, 2026 | 106d | Sep 21, 2026 |
M Medtronic, Inc. |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense | Neurology | PMA Supplement | Approved | P960009/S531 | May 20, 2026 | 90d | Sep 21, 2026 |
M Medtronic Neuromodulation |
Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and … | Neurology | PMA Supplement | Approved | P840001/S620 | May 20, 2026 | 90d | Sep 21, 2026 |
Z ZOLL Medical Corporation |
SurePower I; SurePower II | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160022/S052 | May 20, 2026 | 8d | Sep 21, 2026 |
C Carl Zeiss Meditec, Inc. |
Visumax Femtosecond Laser | Ophthalmic | PMA Supplement | Approved (30-day notice) | P150040/S025 | May 20, 2026 | 29d | Sep 21, 2026 |
A AutoGenomics, Inc. |
AvertD and AvertD Buccal Sample Collection Kit | Other | PMA Supplement | Approved | P230032/S005 | May 20, 2026 | 28d | Sep 21, 2026 |
E Endospan , Ltd. |
NEXUS® Aortic Arch Stent Graft System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250033/S001 | May 20, 2026 | 27d | Sep 21, 2026 |
B Biomet, Inc. |
Taperloc® Complete Hip Stem | Orthopedic | 510(k) | Cleared | K251270 | May 19, 2026 | 390d | Sep 21, 2026 |
S Shenzhen Soga Technology Co., Ltd. |
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) … | Surgical | 510(k) | Cleared | K253309 | May 19, 2026 | 232d | Sep 21, 2026 |
O Orthofix Srl |
Fitbone® Transport And Lengthening System | Orthopedic | 510(k) | Cleared | K260146 | May 19, 2026 | 119d | Sep 21, 2026 |
D DiaDent Group International |
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | Dental | 510(k) | Cleared | K261071 | May 19, 2026 | 48d | Sep 21, 2026 |
B Bernhard Förster GmbH (Bernhard Foerster Ltd.) |
OrthoEasy Pal; OrthoEasy Pal Long Neck | Dental | 510(k) | Cleared | K260268 | May 19, 2026 | 111d | Sep 21, 2026 |
L Luminex Corporation |
LIAISON PLEX Gastrointestinal Flex Assay | Diagnostics | 510(k) | Cleared | K253722 | May 19, 2026 | 176d | Sep 21, 2026 |
M Multi Radiance Medical, Inc. |
MR5 Activ Pro | Physical Medicine | 510(k) | Cleared | K254024 | May 19, 2026 | 154d | Sep 21, 2026 |
P Pegavision Corporation |
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses … | Ophthalmic | 510(k) | Cleared | K261299 | May 19, 2026 | 29d | Sep 21, 2026 |
M Maine Molecular Quality Controls, Inc. |
FilmArray TF Control Panel M527 | Diagnostics | 510(k) | Cleared | K260577 | May 19, 2026 | 88d | Sep 21, 2026 |
S Sejong Medical Co., Ltd. |
Laport | Other | 510(k) | Cleared | K252985 | May 19, 2026 | 243d | Sep 21, 2026 |
B Boston Scientific |
INGEVITY MRI; INGEVITY+; INGEVITY+ Passive | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150012/S184 | May 19, 2026 | 27d | Sep 21, 2026 |
G Guardant Health, Inc. |
Guardant360® Liquid CDx | Diagnostics | PMA | Approved | P250027 | May 19, 2026 | 292d | Sep 21, 2026 |
A Abbott Molecular, Inc. |
Alinity m HR HPV | Diagnostics | PMA Supplement | Approved (30-day notice) | P230003/S016 | May 19, 2026 | 15d | Sep 21, 2026 |
J Johnson & Johnson Surgical Vision, Inc. |
TECNIS Eyhance Toric II IOLs with SmartLOAD Delivery Technology (GIU150-600) | Ophthalmic | PMA Supplement | Approved | P980040/S182 | May 19, 2026 | 81d | Sep 21, 2026 |
M Merz North America, Inc. |
Belotero Volume (+) Lidocaine | Surgical | PMA | Approved | P250020 | May 19, 2026 | 327d | Sep 21, 2026 |
A Aerin Medical, Inc. |
RhinAer+ Stylus | Surgical | 510(k) | Cleared | K260522 | May 18, 2026 | 90d | Sep 21, 2026 |
B Boston Scientific Corporation |
MOSES Raydar | Surgical | 510(k) | Cleared | K260100 | May 18, 2026 | 125d | Sep 21, 2026 |
E ETHICON, Inc. |
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | Surgical | 510(k) | Cleared | K252047 | May 18, 2026 | 322d | Sep 21, 2026 |
C Cercare Medical A/S |
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Imaging | 510(k) | Cleared | K253831 | May 18, 2026 | 168d | Sep 21, 2026 |
H Hollister Incorporated |
Coude Sleeved IC; Coude Plus Sleeved IC | Other | 510(k) | Cleared | K253295 | May 18, 2026 | 231d | Sep 21, 2026 |
O O&M Halyard, Inc. |
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap … | General Hospital | 510(k) | Cleared | K253454 | May 18, 2026 | 227d | Sep 21, 2026 |
G GC America, Inc. |
G-Cem Universal | Dental | 510(k) | Cleared | K254109 | May 18, 2026 | 150d | Sep 21, 2026 |
J JenaValve Technology, Inc. |
Trilogy Transcatheter Heart Valve System | Cardiovascular | PMA Supplement | Approved | P250024/S001 | May 18, 2026 | 32d | Sep 21, 2026 |
E Endomagnetics Ltd. |
MagtraceTM and Sentimag(R) Magnetic Locatization System | Surgical | PMA Supplement | Approved (30-day notice) | P160053/S012 | May 18, 2026 | 62d | Sep 21, 2026 |
H Heartsine Technologies, Ltd. |
HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160008/S034 | May 18, 2026 | 25d | Sep 21, 2026 |
B Boston Scientific Corp |
Vercise Deep Brain Stimulation (DBS) Systems | Neurology | PMA Supplement | Approved (30-day notice) | P150031/S094 | May 18, 2026 | 13d | Sep 21, 2026 |
B Boston Scientific Corp |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System … | Cardiovascular | PMA Supplement | Approved | P130013/S084 | May 18, 2026 | 90d | Sep 21, 2026 |
B Boston Scientific Corp |
Precision Spinal Cord Stimulator (SCS) Systems | Neurology | PMA Supplement | Approved (30-day notice) | P030017/S395 | May 18, 2026 | 13d | Sep 21, 2026 |
J JenaValve Technology, Inc. |
Trilogy Transcatheter Heart Valve System | Cardiovascular | PMA Supplement | Approved | P250024/S002 | May 18, 2026 | 32d | Sep 21, 2026 |
B Boston Scientific Corp |
AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone | Other | PMA Supplement | Approved | N970012/S211 | May 18, 2026 | 90d | Sep 21, 2026 |
L L&K BIOMED Co., Ltd. |
BluEX Cervical Expandable Cage System | Orthopedic | 510(k) | Cleared | K260840 | May 16, 2026 | 61d | Sep 14, 2026 |
T Teleflex Medical Sdn. Bhd. |
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Anesthesiology | 510(k) | Cleared | K252643 | May 15, 2026 | 267d | Sep 14, 2026 |
S Spinal Elements, Inc. |
Ventana® P/T Lumbar Interbody System | Orthopedic | 510(k) | Cleared | K260506 | May 15, 2026 | 87d | Sep 14, 2026 |
B Boston Scientific Corporation |
TruSelect 2.6 Microcatheter | Cardiovascular | 510(k) | Cleared | K260771 | May 15, 2026 | 67d | Sep 14, 2026 |
K Kyocera Medical Technologies Inc. (KMTI) |
Varion Thoracolumbar Fixation System | Orthopedic | 510(k) | Cleared | K260989 | May 15, 2026 | 51d | Sep 14, 2026 |
N Neurophet., Inc. |
Neurophet SCALE PET | Imaging | 510(k) | Cleared | K252563 | May 15, 2026 | 274d | Sep 14, 2026 |
D Depuy Ireland UC |
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Orthopedic | 510(k) | Cleared | K260536 | May 15, 2026 | 87d | Sep 14, 2026 |
A Alife Health |
Embryo Predict | Women's Health | 510(k) | Cleared | K250781 | May 15, 2026 | 427d | Sep 14, 2026 |
B Bausch and Lomb |
Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite … | Ophthalmic | 510(k) | Cleared | K261264 | May 15, 2026 | 29d | Sep 14, 2026 |
B B.Braun Medical, Inc. |
Introcan Safety® Deep Access XL IV Catheter | General Hospital | 510(k) | Cleared | K253235 | May 15, 2026 | 228d | Sep 14, 2026 |
M medXion Technologies, Inc. |
medXion NEXUS | Imaging | 510(k) | Cleared | K253935 | May 15, 2026 | 157d | Sep 14, 2026 |
S Suzhou AcuVu Medical Technology Co., Ltd. |
Manual Tissue Removal Device | Women's Health | 510(k) | Cleared | K254050 | May 15, 2026 | 149d | Sep 14, 2026 |
S Sonoscape Medical Corp. |
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75 … | Imaging | 510(k) | Cleared | K254028 | May 15, 2026 | 150d | Sep 14, 2026 |
W Wuhan United Imaging Healthcare Co.,Ltd |
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse … | Imaging | 510(k) | Cleared | K253716 | May 15, 2026 | 172d | Sep 14, 2026 |
N Neurophet., Inc. |
Neurophet AQUA | Imaging | 510(k) | Cleared | K261273 | May 15, 2026 | 28d | Sep 14, 2026 |
M Medicrea International S.A.S. (Medtronic) |
UNiD Spine Analyzer (SW3002) | Imaging | 510(k) | Cleared | K261289 | May 15, 2026 | 25d | Sep 14, 2026 |
S Subtle Medical, Inc. |
SubtleHD-CT (1.x) | Imaging | 510(k) | Cleared | K254120 | May 15, 2026 | 147d | Sep 14, 2026 |
K KARL STORZ Endoscopy-America, Inc. |
KARL STORZ Laryngoscopes and Accessories | Other | 510(k) | Cleared | K252624 | May 15, 2026 | 270d | Sep 14, 2026 |
R Roche Molecular Systems, Inc. |
cobas liat CT/NG nucleic acid test | Diagnostics | 510(k) | Cleared | K253756 | May 15, 2026 | 171d | Sep 14, 2026 |
B Bain Medical Equipment (Guangzhou) Co., Ltd. |
NovaLine Tubing Set for Hemodialysis (BL 124) | Other | 510(k) | Cleared | K252423 | May 15, 2026 | 287d | Sep 14, 2026 |
O Organon, LLC |
Jada System (Jada-2002) | Women's Health | 510(k) | Cleared | K253642 | May 15, 2026 | 177d | Sep 14, 2026 |
F Fresenius Medical Care Renal Therapies Group, LLC |
NxStage System One with NxView | Other | 510(k) | Cleared | K252377 | May 15, 2026 | 289d | Sep 14, 2026 |
R Roche Molecular Systems, Inc. |
cobas liat CT/NG/MG nucleic acid test | Diagnostics | 510(k) | Cleared | K253759 | May 15, 2026 | 171d | Sep 14, 2026 |
S Shenzhen Root Innovation Technology Co., Ltd. |
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 … | Surgical | 510(k) | Cleared | K260134 | May 15, 2026 | 119d | Sep 14, 2026 |
H Hycor Biomedical |
NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa) … | Diagnostics | 510(k) | Cleared | K260059 | May 15, 2026 | 127d | Sep 14, 2026 |
B Biotronik, Inc. |
Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes | Cardiovascular | PMA Supplement | Approved (30-day notice) | P950037/S292 | May 15, 2026 | 28d | Sep 14, 2026 |
B Boston Scientific |
Vein Pick (Model 6541) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P830060/S093 | May 15, 2026 | 28d | Sep 14, 2026 |
B Boston Scientific Corp |
ACUITY X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY X4 Flushing Tool/Wire Guide (Model 4604) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010012/S608 | May 15, 2026 | 28d | Sep 14, 2026 |
A Abbott Medical |
TactiFlex Ablation Catheter, Sensor Enabled (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-TFSE-DD; A-TFSE-DF; A-TFSE-FF … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P220013/S029 | May 15, 2026 | 31d | Sep 14, 2026 |
B Boston Scientific |
Hex Wrench (#2) (Model 6501) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P930035/S037 | May 15, 2026 | 28d | Sep 14, 2026 |
V Ventana Medical Systems, Inc. |
HER2 Dual ISH DNA Probe Cocktail | Diagnostics | PMA Supplement | Approved | P190031/S015 | May 15, 2026 | 273d | Sep 14, 2026 |
B Boston Scientific |
DF-1 Plug (Model 6996) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P910077/S199 | May 15, 2026 | 28d | Sep 14, 2026 |