| Company | Device | Category | Pathway | Decision | FDA ID | Decision Date | Review | Archived |
|---|---|---|---|---|---|---|---|---|
A Abbott Medical |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Neurology | PMA Supplement | Approved | P010032/S249 | Apr 25, 2026 | 29d | Aug 24, 2026 |
A Abbott Medical |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | Neurology | PMA Supplement | Approved | P140009/S130 | Apr 25, 2026 | 29d | Aug 24, 2026 |
R Roche Diagnostics GmbH |
Elecsys Calcitonin | Diagnostics | 510(k) | Cleared | K252431 | Apr 24, 2026 | 266d | Aug 24, 2026 |
D Diazyme Laboratories, Inc. |
Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Other | 510(k) | Cleared | K252336 | Apr 24, 2026 | 270d | Aug 24, 2026 |
A Applied Medical Resources Corporation |
Alexis lighted wound protector-retractor, flexible, extra small (cl312) … | Surgical | 510(k) | Cleared | K260982 | Apr 24, 2026 | 30d | Aug 24, 2026 |
I I.T.S. GmbH |
I.T.S. PRS Phoenix II | Orthopedic | 510(k) | Cleared | K260054 | Apr 24, 2026 | 106d | Aug 24, 2026 |
Z Zsfab, Inc. |
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Orthopedic | 510(k) | Cleared | K260549 | Apr 24, 2026 | 65d | Aug 24, 2026 |
B Broncus Medical, Inc. |
LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Imaging | 510(k) | Cleared | K260009 | Apr 24, 2026 | 112d | Aug 24, 2026 |
G Guangzhou Longest Medical Technology Co., Ltd. |
Compression Therapy Device (LGT-2202DVT) | Cardiovascular | 510(k) | Cleared | K250242 | Apr 24, 2026 | 452d | Aug 24, 2026 |
M Micro-Tech (Nanjing) Co., Ltd. |
Visualized Access and Delivery Catheter; PB Digital Controller | Other | 510(k) | Cleared | K252492 | Apr 24, 2026 | 259d | Aug 24, 2026 |
S Shanghai Draeger Medical Instrument Co., Ltd. |
Vista CMS | Cardiovascular | 510(k) | Cleared | K250349 | Apr 24, 2026 | 441d | Aug 24, 2026 |
S Siemens Medical Solutions USA, Inc. |
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Imaging | 510(k) | Cleared | K254173 | Apr 24, 2026 | 122d | Aug 24, 2026 |
A Abbott Medical |
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933) … | Imaging | 510(k) | Cleared | K253459 | Apr 24, 2026 | 199d | Aug 24, 2026 |
S Stryker Spine |
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute … | Orthopedic | 510(k) | Cleared | K261008 | Apr 24, 2026 | 29d | Aug 24, 2026 |
M Mirco-Tech (Nanjing) Co., Ltd. |
Dilation Balloon Catheter | Other | 510(k) | Cleared | K253832 | Apr 24, 2026 | 144d | Aug 24, 2026 |
C Chest Wall Innovations, Inc. |
PC Fix System | Orthopedic | 510(k) | Cleared | K260411 | Apr 24, 2026 | 74d | Aug 24, 2026 |
F Flosonics Medical |
FloPatch FP120 | Cardiovascular | 510(k) | Cleared | K252810 | Apr 24, 2026 | 233d | Aug 24, 2026 |
A Abbott |
Amplatzer TorqVue Delivery System | Cardiovascular | 510(k) | Cleared | K260993 | Apr 24, 2026 | 29d | Aug 24, 2026 |
M Mequ A/S |
°M Warmer System with °M Station | General Hospital | 510(k) | Cleared | K260988 | Apr 24, 2026 | 30d | Aug 24, 2026 |
B Bonebridge AG |
POYA 3.5mm Medial Proximal Tibia System | Orthopedic | 510(k) | Cleared | K260228 | Apr 24, 2026 | 88d | Aug 24, 2026 |
P Pixee Medical S.A.S. |
Knee+ | Neurology | 510(k) | Cleared | K253805 | Apr 24, 2026 | 147d | Aug 24, 2026 |
W Wellspect AB |
LoFric Elle Pro | Other | 510(k) | Cleared | K260999 | Apr 24, 2026 | 29d | Aug 24, 2026 |
P Penumbra, Inc. |
INDIGO® Aspiration System INDIGO Link | Cardiovascular | 510(k) | Cleared | K260599 | Apr 24, 2026 | 59d | Aug 24, 2026 |
G Globus Medical, Inc. |
AUTOBAHN Nailing System | Orthopedic | 510(k) | Cleared | K261043 | Apr 24, 2026 | 24d | Aug 24, 2026 |
E Epic Medical Pte. , Ltd. |
SMARTeZ Elastomeric Infusion Pump (RS series) | General Hospital | 510(k) | Cleared | K250234 | Apr 24, 2026 | 452d | Aug 24, 2026 |
T Tandem Diabetes Care, Inc. |
Control-IQ+ technology | Diagnostics | 510(k) | Cleared | K260429 | Apr 24, 2026 | 73d | Aug 24, 2026 |
I Implantcast GmbH |
EPORE® XO cup system | Orthopedic | 510(k) | Cleared | K252451 | Apr 24, 2026 | 263d | Aug 24, 2026 |
E Edgecare, Inc. |
EdgeFlow Gel Pad | Imaging | 510(k) | Cleared | K252337 | Apr 24, 2026 | 270d | Aug 24, 2026 |
M Medtronic, Inc. |
OmniaSecure MRI SureScan Lead Model 3930M | Cardiovascular | PMA Supplement | Approved | P240036/S006 | Apr 24, 2026 | 30d | Aug 24, 2026 |
B Boston Scientific Corporation |
RANGER Paclitaxel-Coated PTA Balloon Catheter | Cardiovascular | PMA Supplement | Approved (30-day notice) | P190019/S042 | Apr 24, 2026 | 30d | Aug 24, 2026 |
B Biotronik Nro, Inc. |
Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management | Neurology | PMA Supplement | Approved (30-day notice) | P210037/S015 | Apr 24, 2026 | 28d | Aug 24, 2026 |
A Abbott Medical |
Optisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P030054/S444 | Apr 24, 2026 | 30d | Aug 24, 2026 |
A Abbott Medical |
Assurity, Assurity+, Endurity, Accent family of Pacemakers | Cardiovascular | PMA Supplement | Approved | P880086/S346 | Apr 24, 2026 | 88d | Aug 24, 2026 |
B Biotronik, Inc. |
Renamic Neo | Cardiovascular | PMA Supplement | Approved | P050023/S207 | Apr 24, 2026 | 86d | Aug 24, 2026 |
O Ophtec BV |
ARTISAN Myopia Models 204US1W and 206US1W | Ophthalmic | PMA Supplement | Approved (30-day notice) | P030028/S013 | Apr 24, 2026 | 163d | Aug 24, 2026 |
A Abbott Medical |
Durata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P950022/S152 | Apr 24, 2026 | 30d | Aug 24, 2026 |
M Medtronic, Inc. |
OmniaSecure MRI SureScan Lead Model 3930M | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240036/S005 | Apr 24, 2026 | 30d | Aug 24, 2026 |
B Biotronik, Inc. |
Renamic Neo | Cardiovascular | PMA Supplement | Approved | P950037/S285 | Apr 24, 2026 | 86d | Aug 24, 2026 |
B Biotronik, Inc. |
Renamic Neo | Cardiovascular | PMA Supplement | Approved | P000009/S127 | Apr 24, 2026 | 86d | Aug 24, 2026 |
A Abbott Medical |
Aveir Leadless System | Cardiovascular | PMA Supplement | Approved | P150035/S037 | Apr 24, 2026 | 88d | Aug 24, 2026 |
A Abbott Medical |
Assurity MRI, Endurity MRI family of Pacemakers | Cardiovascular | PMA Supplement | Approved | P140033/S102 | Apr 24, 2026 | 88d | Aug 24, 2026 |
A Advanced Breath Diagnostics |
13C-Spirulina Gastric Emptying Breath Test (GEBT) | Diagnostics | PMA Supplement | Approved | P110015/S012 | Apr 24, 2026 | 254d | Aug 24, 2026 |
B Biotronik, Inc. |
Renamic Neo | Cardiovascular | PMA Supplement | Approved | P070008/S175 | Apr 24, 2026 | 86d | Aug 24, 2026 |
A Abbott Medical |
Microny family of Pacemakers | Cardiovascular | PMA Supplement | Approved | P970013/S100 | Apr 24, 2026 | 88d | Aug 24, 2026 |
A Abbott Medical |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura … | Cardiovascular | PMA Supplement | Approved | P030054/S442 | Apr 24, 2026 | 88d | Aug 24, 2026 |
A Abbott Medical |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs | Cardiovascular | PMA Supplement | Approved | P910023/S484 | Apr 24, 2026 | 88d | Aug 24, 2026 |
A Abbott Medical |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps | Cardiovascular | PMA Supplement | Approved | P030035/S212 | Apr 24, 2026 | 88d | Aug 24, 2026 |
V Varian Medical Systems, Inc. |
ProBeam 360 Proton Therapy System v3.0 | Imaging | 510(k) | Cleared | K252815 | Apr 23, 2026 | 231d | Aug 24, 2026 |
L Lunit, Inc. |
Lunit INSIGHT MMG (v1.1.10) | Imaging | 510(k) | Cleared | K260320 | Apr 23, 2026 | 83d | Aug 24, 2026 |
C Cardiocycle Medical(Suzhou) Co., Ltd. |
Introducer Sheath Set | Cardiovascular | 510(k) | Cleared | K254248 | Apr 23, 2026 | 115d | Aug 24, 2026 |
M Monteris Medical |
NeuroBlate System | Surgical | 510(k) | Cleared | K260976 | Apr 23, 2026 | 30d | Aug 24, 2026 |
C Cortex, Inc. |
OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cardiovascular | 510(k) | Cleared | K261012 | Apr 23, 2026 | 27d | Aug 24, 2026 |
O Olympus Medical Systems Corp. |
Evis Exera Iii Bronchovideoscope (Olympus Bf-Q190); Evis Exera Iii Bronchovideoscope (Olympus Bf-H190 ) … | Other | 510(k) | Cleared | K252341 | Apr 23, 2026 | 269d | Aug 24, 2026 |
T Tusker Medical, Inc. |
Tula Tympanostomy Tube Delivery Device | Other | 510(k) | Cleared | K252436 | Apr 23, 2026 | 265d | Aug 24, 2026 |
M Mv Life, LLC |
OxyGo Portable Oxygen Concentrator (1400-7000) | Anesthesiology | 510(k) | Cleared | K252407 | Apr 23, 2026 | 266d | Aug 24, 2026 |
D Dentsply Sirona |
DS Core CBCT Anatomy | Imaging | 510(k) | Cleared | K260785 | Apr 23, 2026 | 44d | Aug 24, 2026 |
S Smwmed, Inc. |
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Cardiovascular | 510(k) | Cleared | K252389 | Apr 23, 2026 | 266d | Aug 24, 2026 |
M Medtronic, Inc. |
Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Cardiovascular | 510(k) | Cleared | K260195 | Apr 23, 2026 | 91d | Aug 24, 2026 |
N Neocoil, LLC |
0.55T 12Ch Breast Coil | Imaging | 510(k) | Cleared | K260947 | Apr 23, 2026 | 31d | Aug 24, 2026 |
S Siemens Medical Solutions USA, Inc. |
ARTIS genio floor; ARTIS icono.explore floor | Imaging | 510(k) | Cleared | K253752 | Apr 23, 2026 | 149d | Aug 24, 2026 |
C CliniComp, Intl. |
Cci Pacs Viewer (Pacs-Us-001) | Imaging | 510(k) | Cleared | K254237 | Apr 23, 2026 | 115d | Aug 24, 2026 |
M Medtronic Interventional Vascular, Inc. |
Liberant RX Aspiration Catheter | Cardiovascular | 510(k) | Cleared | K253589 | Apr 23, 2026 | 157d | Aug 24, 2026 |
M Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. |
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Dental | 510(k) | Cleared | K260152 | Apr 23, 2026 | 93d | Aug 24, 2026 |
C Cardiva Medical, Inc. |
Cardiva, VASCADE Family | Cardiovascular | PMA Supplement | Approved | P120016/S040 | Apr 23, 2026 | 114d | Aug 24, 2026 |
I Illumina, Inc. |
TruSight Oncology Comprehensive | Diagnostics | PMA Supplement | Approved | P230011/S007 | Apr 23, 2026 | 27d | Aug 24, 2026 |
A Alcon Research, LLC |
Hydrus® Microstent | Ophthalmic | PMA Supplement | Approved (30-day notice) | P170034/S017 | Apr 23, 2026 | 27d | Aug 24, 2026 |
M Medtronic, Inc. |
Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P980035/S840 | Apr 23, 2026 | 29d | Aug 24, 2026 |
T Teleflex Medical, LLC |
MANTA Vascular Closure Device | Cardiovascular | PMA Supplement | Approved (30-day notice) | P180025/S016 | Apr 23, 2026 | 31d | Aug 24, 2026 |
R Roche Molecular Systems, Inc. |
cobas® HPV | Diagnostics | PMA Supplement | Approved | P190028/S024 | Apr 23, 2026 | 84d | Aug 24, 2026 |
M Medtronic, Inc. |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140010/S102 | Apr 23, 2026 | 29d | Aug 24, 2026 |
M Medtronic Cryocath, LP |
Freezor MAX 209F3,209F5 | Cardiovascular | PMA Supplement | Approved | P100010/S153 | Apr 23, 2026 | 85d | Aug 24, 2026 |
M Medtronic Vascular, Inc. |
IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter | Cardiovascular | PMA Supplement | Approved (30-day notice) | P190008/S047 | Apr 23, 2026 | 29d | Aug 24, 2026 |
B Boston Scientific Corp |
WATCHMAN FLXTM Left Atrial Appendage Closure Device with Delivery System … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130013/S085 | Apr 23, 2026 | 17d | Aug 24, 2026 |
M Medtronic Cryocath, LP |
Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5 | Cardiovascular | PMA Supplement | Approved | P020045/S113 | Apr 23, 2026 | 85d | Aug 24, 2026 |
M Medtronic, Inc. |
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010015/S585 | Apr 23, 2026 | 29d | Aug 24, 2026 |
M Medtronic Vascular, Inc. |
Everflex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110023/S067 | Apr 23, 2026 | 30d | Aug 24, 2026 |
S Steritec Products |
Verrix EVA STEAM Biological Indicator (BI) (Model: 1200) … | General Hospital | 510(k) | Cleared | K252306 | Apr 22, 2026 | 272d | Aug 24, 2026 |
E Ever Fortune.Ai, Co., Ltd. |
Efai Ersuite Ct Appendicitis Assessment System (Appen-Ct-100) | Imaging | 510(k) | Cleared | K253163 | Apr 22, 2026 | 208d | Aug 24, 2026 |
C Carlsmed, Inc. |
corra cervical plating system | Orthopedic | 510(k) | Cleared | K260570 | Apr 22, 2026 | 62d | Aug 24, 2026 |
J Jiangxi AOV Maternity & Baby Products Co., Ltd. |
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Women's Health | 510(k) | Cleared | K260239 | Apr 22, 2026 | 86d | Aug 24, 2026 |
O Otto Bock Healthcare Products GmbH |
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Neurology | 510(k) | Cleared | K253256 | Apr 22, 2026 | 205d | Aug 24, 2026 |
E Erbe Elektromedizin GmbH |
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Surgical | 510(k) | Cleared | K253230 | Apr 22, 2026 | 205d | Aug 24, 2026 |
D Ddc Technologies, Inc. |
Vanish Pro | Surgical | 510(k) | Cleared | K253765 | Apr 22, 2026 | 148d | Aug 24, 2026 |
N Nooance |
Led Facial Mask (Mj-66Db, Mk-99, Mk-99A, Mk-99M, Mj-66C) | Surgical | 510(k) | Cleared | K260150 | Apr 22, 2026 | 92d | Aug 24, 2026 |
W Wuyi Aichi Industry and Trade Co., Ltd. |
Mobility Scooter (X-12, X-14, X-17) | Physical Medicine | 510(k) | Cleared | K260237 | Apr 22, 2026 | 86d | Aug 24, 2026 |
S Shanghai United Imaging Healthcare Co., Ltd. |
uOmnispace.MR | Imaging | 510(k) | Cleared | K253077 | Apr 22, 2026 | 211d | Aug 24, 2026 |
B Boston Scientific |
RELIANCE S Active Fix Single Coil IS-1/DF-1 59cm (Model 0137) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P910073/S189 | Apr 22, 2026 | 30d | Aug 24, 2026 |
E Exact Sciences Corporation |
Cologuard® | Diagnostics | PMA Supplement | Approved (30-day notice) | P130017/S069 | Apr 22, 2026 | 26d | Aug 24, 2026 |
B Boston Scientific Corp |
ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010012/S606 | Apr 22, 2026 | 30d | Aug 24, 2026 |
E Exact Sciences Corporation |
Cologuard Plus | Diagnostics | PMA Supplement | Approved (30-day notice) | P230043/S008 | Apr 22, 2026 | 26d | Aug 24, 2026 |
M Medtronic, Inc. |
Micra Transcatheter Pacing System | Cardiovascular | PMA Supplement | Approved | P150033/S225 | Apr 22, 2026 | 33d | Aug 24, 2026 |
T Tiger Aesthetics Medical, LLC |
Sientra Silicone Gel Breast Implants | Surgical | PMA Supplement | Approved (30-day notice) | P070004/S048 | Apr 22, 2026 | 28d | Aug 24, 2026 |
E EvoEndo, Inc. |
EvoEndo Single-Use Endoscopy System | Other | 510(k) | Cleared | K260573 | Apr 21, 2026 | 60d | Aug 24, 2026 |
M Medtronic Sofamor Danek USA, Inc. |
CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Orthopedic | 510(k) | Cleared | K260216 | Apr 21, 2026 | 88d | Aug 24, 2026 |
S Shenzhen Semlamp Intelligent Technology Co., Ltd. |
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352 … | Surgical | 510(k) | Cleared | K260518 | Apr 21, 2026 | 63d | Aug 24, 2026 |
B Beijing Hanvon Health Technology Co., Ltd. |
Korotkoff sound blood pressure monitor | Cardiovascular | 510(k) | Cleared | K253982 | Apr 21, 2026 | 130d | Aug 24, 2026 |
R RhythMedix, LLC |
RhythmStar System (SL) | Cardiovascular | 510(k) | Cleared | K250793 | Apr 21, 2026 | 403d | Aug 24, 2026 |
B bioMérieux SA |
ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | Diagnostics | 510(k) | Cleared | K260447 | Apr 21, 2026 | 69d | Aug 24, 2026 |
S Sonorous NV, Inc. |
BosCATH Support Catheter | Cardiovascular | 510(k) | Cleared | K254046 | Apr 21, 2026 | 125d | Aug 24, 2026 |
T Tigon Medical |
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Orthopedic | 510(k) | Cleared | K260921 | Apr 21, 2026 | 33d | Aug 24, 2026 |
S Siemens Medical Solutions Diagnostics Limited |
IMMULITE 2000 Free PSA | Diagnostics | PMA Supplement | Approved | P060005/S024 | Apr 21, 2026 | 203d | Aug 24, 2026 |
B Boston Scientific |
Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533 … | Cardiovascular | PMA Supplement | Approved | P960040/S507 | Apr 21, 2026 | 251d | Aug 24, 2026 |
S Siemens Healthcare Diagnostics, Inc. |
Immulite 2000 Afp | Diagnostics | PMA Supplement | Approved | P010007/S025 | Apr 21, 2026 | 203d | Aug 24, 2026 |
S Siemens Healthcare Diagnostics, Inc. |
Immulite 2000 Psa | Diagnostics | PMA Supplement | Approved | P930027/S038 | Apr 21, 2026 | 203d | Aug 24, 2026 |
B Boston Scientific Corp |
Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548 … | Cardiovascular | PMA Supplement | Approved | P010012/S594 | Apr 21, 2026 | 251d | Aug 24, 2026 |
N Neuspera Medical, Inc. |
Neuspera Sacral Neuromodulation (SNM) System | Other | PMA Supplement | Approved | P240031/S003 | Apr 21, 2026 | 235d | Aug 24, 2026 |
C Cook, Inc. |
Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P020018/S067 | Apr 21, 2026 | 28d | Aug 24, 2026 |
E Edwards Lifesciences, LLC |
PASCAL Precision Transcatheter Valve Repair System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P220003/S027 | Apr 21, 2026 | 28d | Aug 24, 2026 |
M Medtronic, Inc. |
Sphere-9 Catheter | Cardiovascular | PMA Supplement | Approved | P240013/S024 | Apr 21, 2026 | 28d | Aug 24, 2026 |
S SmartsurgN, Inc. |
SmartSurgN Visualization System | Other | 510(k) | Cleared | K242163 | Apr 20, 2026 | 635d | Aug 24, 2026 |
N Nanjing Bestview Laser S&T Co., Ltd. |
Q-Switched Nd: YAG Laser System (Glamor Q) | Surgical | 510(k) | Cleared | K260153 | Apr 20, 2026 | 90d | Aug 24, 2026 |
A Abbott Medical |
EnSite X EP System | Cardiovascular | 510(k) | Cleared | K260212 | Apr 20, 2026 | 87d | Aug 24, 2026 |
M Mim Fertility |
Folliscan | Imaging | 510(k) | Cleared | K252332 | Apr 20, 2026 | 269d | Aug 24, 2026 |
G GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC |
Lunar Astra | Imaging | 510(k) | Cleared | K252718 | Apr 20, 2026 | 235d | Aug 24, 2026 |
Z Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Power Wheelchair (N5919 series) | Physical Medicine | 510(k) | Cleared | K253806 | Apr 20, 2026 | 143d | Aug 24, 2026 |
L Luminoah |
Luminoah FLOW Enteral Nutrition System | General Hospital | 510(k) | Cleared | K253558 | Apr 20, 2026 | 154d | Aug 24, 2026 |
S Spinex, Inc. |
xStep (xStep) | Physical Medicine | 510(k) | Cleared | K253638 | Apr 20, 2026 | 152d | Aug 24, 2026 |
Z ZheJiang Decans Medical Devices Co., Ltd. |
SAGI Cervical Cage System | Orthopedic | 510(k) | Cleared | K253213 | Apr 20, 2026 | 203d | Aug 24, 2026 |
H Hubei Xinxin Non-Woven Co., Ltd. |
Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025) … | Surgical | 510(k) | Cleared | K253003 | Apr 20, 2026 | 213d | Aug 24, 2026 |
B Biomet Manufacturing Corp |
Oxford® Partial Knee System | Orthopedic | PMA Supplement | Approved (30-day notice) | P010014/S115 | Apr 20, 2026 | 28d | Aug 24, 2026 |
V Vascutek, Ltd. |
Thoraflex Hybrid | Cardiovascular | PMA Supplement | Approved | P210006/S017 | Apr 20, 2026 | 90d | Aug 24, 2026 |
C Conavi Medical, Inc. |
Novasight Hybrid System | Cardiovascular | 510(k) | Cleared | K252945 | Apr 17, 2026 | 214d | Aug 17, 2026 |
P Pontemedag |
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Other | 510(k) | Cleared | K252334 | Apr 17, 2026 | 263d | Aug 17, 2026 |
H Hjarta Care, LLC |
XplantR Explant Tool | Cardiovascular | De Novo | Granted | DEN250033 | Apr 17, 2026 | 253d | Aug 17, 2026 |
L Liofilchem s.r.l. |
MTS Gepotidacin 0.016-256 µg/mL | Diagnostics | 510(k) | Cleared | K260696 | Apr 17, 2026 | 45d | Aug 17, 2026 |
E Edgecare, Inc. |
EdgeFlow UW20 | Imaging | 510(k) | Cleared | K252237 | Apr 17, 2026 | 274d | Aug 17, 2026 |
H Hangzhou SHINING3D Dental Technology Co., Ltd. |
Dura-Arch | Dental | 510(k) | Cleared | K261261 | Apr 17, 2026 | 1d | Aug 17, 2026 |
E Edwards Lifesciences |
Edwards eSheath+ introducer set | Cardiovascular | 510(k) | Cleared | K254279 | Apr 17, 2026 | 108d | Aug 17, 2026 |
M Medartis AG |
TITAN Nail; APTUS K-Wire System | Orthopedic | 510(k) | Cleared | K260934 | Apr 17, 2026 | 28d | Aug 17, 2026 |
S Sensomedical Labs, Ltd. |
Wovyn Depth Electrode | Neurology | 510(k) | Cleared | K253970 | Apr 17, 2026 | 127d | Aug 17, 2026 |
C Chirana T.Injecta,A.S. |
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | General Hospital | 510(k) | Cleared | K252279 | Apr 17, 2026 | 269d | Aug 17, 2026 |
S Somnetics International, Inc. (Dba Transcend Inc) |
MySleepDash | Anesthesiology | 510(k) | Cleared | K252338 | Apr 17, 2026 | 263d | Aug 17, 2026 |
V Vilex, LLC |
DYNEX® External Fixation Systems | Orthopedic | 510(k) | Cleared | K260900 | Apr 17, 2026 | 30d | Aug 17, 2026 |
N Navi Medical Technologies |
Neonav ECG Tip Location System | General Hospital | 510(k) | Cleared | K260929 | Apr 17, 2026 | 28d | Aug 17, 2026 |
B Biosense Webster, Inc. |
QDOT MICRO System | Cardiovascular | PMA Supplement | Approved | P210027/S016 | Apr 17, 2026 | 21d | Aug 17, 2026 |
V Vistakon, Johnson & Johnson Vision Products, Inc. |
VISTAKON® (etafilcon A) Brand Contact Lenses | Ophthalmic | PMA Supplement | Approved (30-day notice) | N18033/S114 | Apr 17, 2026 | 18d | Aug 17, 2026 |
A Abbott |
CentriMag Circulatory Support System | Cardiovascular | PMA Supplement | Approved | P170038/S029 | Apr 17, 2026 | 74d | Aug 17, 2026 |
A Abbott Vascular Devices |
StarClose SE Vascular Closure System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P050007/S049 | Apr 17, 2026 | 28d | Aug 17, 2026 |
M Medtronic Vascular, Inc. |
VenaSeal Closure System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140018/S049 | Apr 17, 2026 | 29d | Aug 17, 2026 |
V Vistakon, Division of Johnson & Johnson Vision Car |
VISTAKON® (senofilcon A) Brand Contact Lenses | Ophthalmic | PMA Supplement | Approved (30-day notice) | P040045/S142 | Apr 17, 2026 | 18d | Aug 17, 2026 |
A Abbott Vascular, Inc. |
Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960043/S133 | Apr 17, 2026 | 28d | Aug 17, 2026 |
S Shenzhen Maiwei Biotech Co., Ltd. |
High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Cardiovascular | 510(k) | Cleared | K253048 | Apr 16, 2026 | 206d | Aug 17, 2026 |
F Foundation Surgical Group, Inc. |
Foundation Surgical Navigated Lateral Disc Prep Instruments | Neurology | 510(k) | Cleared | K260011 | Apr 16, 2026 | 104d | Aug 17, 2026 |
S SpineCraft |
ORIO-3D Cage System | Orthopedic | 510(k) | Cleared | K253260 | Apr 16, 2026 | 199d | Aug 17, 2026 |
P Promisemed Hangzhou Meditech Co., Ltd. |
Verisafe Safety Sterile Needles (SSN) | General Hospital | 510(k) | Cleared | K254273 | Apr 16, 2026 | 107d | Aug 17, 2026 |
G Golden Isles Medical, Inc. |
Julva Velvé Water-Based Personal Lubricant | Women's Health | 510(k) | Cleared | K254101 | Apr 16, 2026 | 118d | Aug 17, 2026 |
A Abbott Medical |
Disposable Radiofrequency Cannula | Neurology | 510(k) | Cleared | K253907 | Apr 16, 2026 | 132d | Aug 17, 2026 |
S Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Cardiovascular | 510(k) | Cleared | K253170 | Apr 16, 2026 | 202d | Aug 17, 2026 |
X Xodus Medical, Inc. |
Hot Pink Pad Warming System | Cardiovascular | 510(k) | Cleared | K260903 | Apr 16, 2026 | 29d | Aug 17, 2026 |
M Medi-Globe GmbH |
Endoflux Biliary & Pancreatic Stent Sets | Other | 510(k) | Cleared | K251658 | Apr 16, 2026 | 321d | Aug 17, 2026 |
B Bright Uro, Inc. |
Glean Urodynamics System Male Delivery System (GUS-1000-M) … | Other | 510(k) | Cleared | K253537 | Apr 16, 2026 | 154d | Aug 17, 2026 |
H Hinge Health, Inc. |
Enso for Migraine | Neurology | 510(k) | Cleared | K254216 | Apr 16, 2026 | 108d | Aug 17, 2026 |
S Strauss Surgical USA |
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0° … | Other | 510(k) | Cleared | K253892 | Apr 16, 2026 | 133d | Aug 17, 2026 |
T Terrats Medical SL |
DESS Dental Smart Solutions | Dental | 510(k) | Cleared | K253804 | Apr 16, 2026 | 139d | Aug 17, 2026 |
F Finemedix Co., Ltd. |
ClearTip TBNA Type | Other | 510(k) | Cleared | K251478 | Apr 16, 2026 | 338d | Aug 17, 2026 |
B Balt USA, LLC |
Next Generation 088 Catheter | Cardiovascular | 510(k) | Cleared | K254223 | Apr 16, 2026 | 108d | Aug 17, 2026 |
G Guangdong Optomedic Technologies, Inc. |
Insufflator (OPTO-IFL1000) | Women's Health | 510(k) | Cleared | K252318 | Apr 16, 2026 | 265d | Aug 17, 2026 |
L Life Spine, Inc. |
ARx® SAI Implant System | Orthopedic | 510(k) | Cleared | K254274 | Apr 16, 2026 | 107d | Aug 17, 2026 |
S Spinal Simplicity |
Freedom DS Decompression System | Orthopedic | 510(k) | Cleared | K253523 | Apr 16, 2026 | 154d | Aug 17, 2026 |
S Suzhou Zenith Vascular SciTech Limited |
Zenith Micro Guidewire | Cardiovascular | 510(k) | Cleared | K252317 | Apr 16, 2026 | 265d | Aug 17, 2026 |
B Beijing Kreate Medical Co., Ltd. |
Redermo Wound Matrix | Other | 510(k) | Cleared | K260020 | Apr 16, 2026 | 101d | Aug 17, 2026 |
A Advanced Bionics |
HiResolution Bionic Ear System | Other | PMA Supplement | Approved (30-day notice) | P960058/S175 | Apr 16, 2026 | 30d | Aug 17, 2026 |
A Advanced Bionics |
HiResolution Bionic Ear System | Other | PMA Supplement | Approved | P960058/S173 | Apr 16, 2026 | 93d | Aug 17, 2026 |
E Edwards Lifesciences, LLC |
Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P860057/S225 | Apr 16, 2026 | 29d | Aug 17, 2026 |
I Inspire Medical Systems |
Inspire V Printed Circuit Board Assembly (PCBA) Test System SW | Anesthesiology | PMA Supplement | Approved (30-day notice) | P130008/S138 | Apr 16, 2026 | 29d | Aug 17, 2026 |
E Edwards Lifesciences, LLC |
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, SAPIEN 3 Ultra Transcatheter Heart Valve System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140031/S201 | Apr 16, 2026 | 29d | Aug 17, 2026 |
E Edwards Lifesciences, LLC |
INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Valved Conduit | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150048/S099 | Apr 16, 2026 | 29d | Aug 17, 2026 |
E Edwards Lifesciences, LLC |
EVOQUE Tricuspid Valve Replacement System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230013/S026 | Apr 16, 2026 | 29d | Aug 17, 2026 |
A Abbott Medical |
Volt PFA System | Cardiovascular | PMA Supplement | Approved | P250022/S003 | Apr 16, 2026 | 85d | Aug 17, 2026 |
E Edwards Lifesciences, LLC |
SAPIEN M3 Transcatheter Mitral Valve Replacement System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250019/S003 | Apr 16, 2026 | 29d | Aug 17, 2026 |
D Dentsply Sirona, Inc. |
SureSmile Aligner (ASSY500020) | Dental | 510(k) | Cleared | K260722 | Apr 15, 2026 | 41d | Aug 17, 2026 |
C Crossroads Neurovascular, Inc. |
Path Bgc | Cardiovascular | 510(k) | Cleared | K260938 | Apr 15, 2026 | 26d | Aug 17, 2026 |
I Immunodiagnostic Systems Limited |
IDS-iSYS Total Testosterone | Diagnostics | 510(k) | Cleared | K252728 | Apr 15, 2026 | 230d | Aug 17, 2026 |
Q Q-Linea AB |
ASTar BC G- Kit | Diagnostics | 510(k) | Cleared | K253573 | Apr 15, 2026 | 149d | Aug 17, 2026 |
S Shenzhen Kaiyan Medical Equipment Co., Ltd. |
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Surgical | 510(k) | Cleared | K260129 | Apr 15, 2026 | 89d | Aug 17, 2026 |
Z ZheJiang Decans Medical Devices Co., Ltd. |
Uni-C Cervical Cage System | Orthopedic | 510(k) | Cleared | K252774 | Apr 15, 2026 | 225d | Aug 17, 2026 |
B bioMerieux, Inc. |
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | Diagnostics | 510(k) | Cleared | K260282 | Apr 15, 2026 | 76d | Aug 17, 2026 |
B Biomet France |
Refobacin Bone Cement R (110034355) | Orthopedic | 510(k) | Cleared | K254107 | Apr 15, 2026 | 117d | Aug 17, 2026 |
P Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla |
Veriqa Rt Epid 3D | Imaging | 510(k) | Cleared | K252258 | Apr 15, 2026 | 268d | Aug 17, 2026 |
I Inter-Med, Inc. |
REGEN Bioactive Cement | Dental | 510(k) | Cleared | K253337 | Apr 15, 2026 | 197d | Aug 17, 2026 |
W Weifang Mingliang Electronics Co., Ltd. |
Diode Laser Therapy Systems (V19) | Surgical | 510(k) | Cleared | K260307 | Apr 15, 2026 | 75d | Aug 17, 2026 |
B Becton, Dickinson and Company |
BD Preset and BD A-Line Arterial Blood Collection Syringes | Diagnostics | 510(k) | Cleared | K260128 | Apr 15, 2026 | 89d | Aug 17, 2026 |
S Sprintray, Inc. |
Midas Restore | Dental | 510(k) | Cleared | K260661 | Apr 15, 2026 | 44d | Aug 17, 2026 |
A Advanced Sterilization Products, Inc. |
STERRAD 100NX Sterilization System with ALLClear Technology (10104) | General Hospital | 510(k) | Cleared | K252843 | Apr 15, 2026 | 219d | Aug 17, 2026 |
B Biomet Orthopedics |
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Orthopedic | 510(k) | Cleared | K252404 | Apr 15, 2026 | 258d | Aug 17, 2026 |
Q Q-Med AB |
Sculptra And Sculptra Aesthetic | Surgical | PMA Supplement | Approved | P030050/S054 | Apr 15, 2026 | 92d | Aug 17, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
CapSure SP Novus Lead (5092); CapSure SP Novus Lead (5592); CapSure SP Novus Lead (5594) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P850089/S174 | Apr 15, 2026 | 15d | Aug 17, 2026 |
G Guardant Health, Inc. |
Shield | Other | PMA Supplement | Approved | P230009/S014 | Apr 15, 2026 | 57d | Aug 17, 2026 |
L Lenstec, Inc. |
Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM | Ophthalmic | PMA Supplement | Approved (30-day notice) | P090022/S049 | Apr 15, 2026 | 27d | Aug 17, 2026 |
I Integrum AB |
OPRA Implant System | Orthopedic | PMA Supplement | Approved | P190009/S011 | Apr 15, 2026 | 90d | Aug 17, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
End Cap (6701), Sizing Sleeve (6920), Upsizing Sleeve (6925) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P900061/S176 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic, Inc. |
Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P080006/S192 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
Adhesive; CapSure Sense Lead (4073,4074); CapSure Sense Lead (4574); CapSure SP Novus Lead (4092) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P830061/S235 | Apr 15, 2026 | 15d | Aug 17, 2026 |
B Biotronik AG |
Orsiro Mission Sirolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved | P170030/S047 | Apr 15, 2026 | 524d | Aug 17, 2026 |
M Medtronic, Inc. |
CapSureFix Lead 5568, CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P930039/S277 | Apr 15, 2026 | 15d | Aug 17, 2026 |
B Biotronik AG |
ORSIRO Sirolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P170030/S062 | Apr 15, 2026 | 30d | Aug 17, 2026 |
M Medtronic, Inc. |
CapSure Epicardial Pacing Lead (4968), CapSure Epicardial Pacing Lead (4965) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P950024/S117 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic, Inc. |
Transvene CS/SVC Lead (6937A) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P980050/S146 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic, Inc. |
Myocardial Pacing Lead | Cardiovascular | PMA Supplement | Approved (30-day notice) | P120017/S040 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic, Inc. |
ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P920015/S305 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic, Inc. |
Epsila EV Extravascular Lead | Cardiovascular | PMA Supplement | Approved (30-day notice) | P220012/S070 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic, Inc. |
CapSure VDD-2 Lead (5038L, 5038S), CapSure VDD-2 Lead (5038), Service Kit-Pacemaker Repair Kit (5873C) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P890003/S486 | Apr 15, 2026 | 15d | Aug 17, 2026 |
L Lenstec, Inc. |
Clearview 3 | Ophthalmic | PMA Supplement | Approved (30-day notice) | P200020/S012 | Apr 15, 2026 | 27d | Aug 17, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
Anchoring Sleeve Kit; SelectSecure Lead | Cardiovascular | PMA Supplement | Approved (30-day notice) | P030036/S159 | Apr 15, 2026 | 15d | Aug 17, 2026 |
M Medtronic, Inc. |
Attain Bipolar OTW Lead; Attain OTW L V Lead | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010015/S586 | Apr 15, 2026 | 15d | Aug 17, 2026 |
A Abbott Medical |
Navitor Transcatheter Aortic Valve Implantation System | Cardiovascular | PMA Supplement | Approved | P190023/S030 | Apr 15, 2026 | 90d | Aug 17, 2026 |
B Biotronik AG |
PRO-Kinetic Energy Coronary Stent System | Cardiovascular | PMA Supplement | Approved | P160003/S022 | Apr 15, 2026 | 524d | Aug 17, 2026 |
C Corcym S.r.l. |
TriMemo SEMIRIGID ANNULOPLASTY RING | Cardiovascular | 510(k) | Cleared | K260498 | Apr 14, 2026 | 60d | Aug 17, 2026 |
U Unimed Medical Supplies, Inc. |
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Cardiovascular | 510(k) | Cleared | K260931 | Apr 14, 2026 | 25d | Aug 17, 2026 |
I Iconic Solutions by Murcia, SL |
Inbentus Versatile | Anesthesiology | 510(k) | Cleared | K252663 | Apr 14, 2026 | 235d | Aug 17, 2026 |
S Spr Therapeutics, Inc. |
SPRINT PNS System | Neurology | 510(k) | Cleared | K240974 | Apr 14, 2026 | 734d | Aug 17, 2026 |
S Shenzhen Dongjiang Technology Co., Ltd. |
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Surgical | 510(k) | Cleared | K253107 | Apr 14, 2026 | 202d | Aug 17, 2026 |
E Exactech, Inc. |
Equinoxe® Shoulder System | Orthopedic | 510(k) | Cleared | K260583 | Apr 14, 2026 | 53d | Aug 17, 2026 |
G Ge Medical Systems, LLC |
Critical Care Suite with Enteric Tube Positioning AI Algorithm | Imaging | 510(k) | Cleared | K253502 | Apr 14, 2026 | 166d | Aug 17, 2026 |
S Shenzhen RF Tech Co., Ltd. |
HD 8Ch Wrist Array | Imaging | 510(k) | Cleared | K252587 | Apr 14, 2026 | 242d | Aug 17, 2026 |
C Cook Ireland, Ltd. |
Zilver® Vena® Venous Self-Expanding Stent | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200023/S009 | Apr 14, 2026 | 29d | Aug 17, 2026 |
Q Q-Med AB |
Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour | Surgical | PMA Supplement | Approved (30-day notice) | P140029/S056 | Apr 14, 2026 | 27d | Aug 17, 2026 |
C Cook Ireland, Ltd. |
Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent | Cardiovascular | PMA Supplement | Approved (30-day notice) | P050017/S026 | Apr 14, 2026 | 29d | Aug 17, 2026 |
K Kestra Medical Technologies, Inc. |
ASSURE Wearable Cardioverter Defibrillator (WCD) System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200037/S019 | Apr 14, 2026 | 25d | Aug 17, 2026 |
C Calyxo, Inc. |
CVAC Aspiration System | Other | 510(k) | Cleared | K260965 | Apr 13, 2026 | 21d | Aug 17, 2026 |
H HC Biologics, LLC |
Hc Biologics Osteopoint Peek Cages, Hc Biologics Osteopoint Cervical Peek Cages … | Orthopedic | 510(k) | Cleared | K260340 | Apr 13, 2026 | 70d | Aug 17, 2026 |
B B-One Ortho, Corp. |
b-ONE® Bipolar Head | Orthopedic | 510(k) | Cleared | K253357 | Apr 13, 2026 | 195d | Aug 17, 2026 |
Z Zimmer, Inc. |
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays … | Orthopedic | 510(k) | Cleared | K253592 | Apr 13, 2026 | 147d | Aug 17, 2026 |
S Shoulder Innovations, Inc. |
InSet Reverse Total Shoulder System | Orthopedic | 510(k) | Cleared | K254128 | Apr 13, 2026 | 112d | Aug 17, 2026 |
H Healgen Scientific,, LLC |
Heal-Check Rapid COVID-19 Antigen Self-Test | Diagnostics | 510(k) | Cleared | K260095 | Apr 13, 2026 | 90d | Aug 17, 2026 |
R Roche Diagnostics |
Elecsys Anti-SARS-CoV-2 S | Diagnostics | 510(k) | Cleared | K252280 | Apr 13, 2026 | 265d | Aug 17, 2026 |
C Corify Care S.L |
Acorys Mapping System | Cardiovascular | 510(k) | Cleared | K253861 | Apr 13, 2026 | 131d | Aug 17, 2026 |
I Inquis Medical |
Aventus Introducer Sheath | Cardiovascular | 510(k) | Cleared | K260091 | Apr 13, 2026 | 91d | Aug 17, 2026 |
V Vapotherm, Inc. |
Hvt 2.0 | Anesthesiology | 510(k) | Cleared | K254078 | Apr 13, 2026 | 116d | Aug 17, 2026 |
A Abbott Medical |
Volt PFA Catheter, Sensor Enabled | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250022/S004 | Apr 13, 2026 | 7d | Aug 17, 2026 |
K Keri Medical SA |
TOUCH® CMC 1 Prosthesis | Orthopedic | PMA Supplement | Approved (30-day notice) | P240020/S005 | Apr 13, 2026 | 31d | Aug 17, 2026 |
B Bolton Medical, Inc. |
RelayPro Thoracic Stent-Graft System | Cardiovascular | PMA Supplement | Approved | P200045/S017 | Apr 13, 2026 | 311d | Aug 17, 2026 |
M Medtronic, Inc. |
PulseSelect Pulse Field Ablation (PFA) Catheter | Cardiovascular | PMA Supplement | Approved | P230017/S010 | Apr 13, 2026 | 34d | Aug 17, 2026 |
B Bolton Medical, Inc. |
TREO® Abdominal Stent-Graft System | Cardiovascular | PMA Supplement | Approved | P190015/S024 | Apr 13, 2026 | 311d | Aug 17, 2026 |
E Eximo Medical |
Auryon Atherectomy System | Cardiovascular | 510(k) | Cleared | K260244 | Apr 10, 2026 | 73d | Aug 10, 2026 |
O Okami Medical, Inc. |
LOBO Vascular Occlusion System | Cardiovascular | 510(k) | Cleared | K260508 | Apr 10, 2026 | 52d | Aug 10, 2026 |
O OrbusNeich Medical (Shenzhen) Co., Ltd. |
Teleport Glide Microcatheter | Cardiovascular | 510(k) | Cleared | K253361 | Apr 10, 2026 | 192d | Aug 10, 2026 |
S Shaeferh, LLC |
ShaeferH | Dental | 510(k) | Cleared | K252942 | Apr 10, 2026 | 207d | Aug 10, 2026 |
R Relu BV |
Relu Cloud | Imaging | 510(k) | Cleared | K252708 | Apr 10, 2026 | 226d | Aug 10, 2026 |
C Cognifisense, Inc. |
VRNT | Neurology | 510(k) | Cleared | K254004 | Apr 10, 2026 | 116d | Aug 10, 2026 |
B Becton, Dickinson and Company |
BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with … | Diagnostics | 510(k) | Cleared | K252506 | Apr 10, 2026 | 245d | Aug 10, 2026 |
R Radiometer Medicals Aps |
ABL90 FLEX PLUS System, safeCLINITUBES | Diagnostics | 510(k) | Cleared | K252207 | Apr 10, 2026 | 270d | Aug 10, 2026 |
S Siemens Healthcare GmbH |
syngo Dynamics (VA41F) | Imaging | 510(k) | Cleared | K253689 | Apr 10, 2026 | 140d | Aug 10, 2026 |
S Siemens Healthcare GmbH |
AI-Rad Companion Organs RT | Imaging | 510(k) | Cleared | K252548 | Apr 10, 2026 | 240d | Aug 10, 2026 |
A Aitewan Biomedical Technology, Inc. |
DeepBT Detector-Plus | Imaging | 510(k) | Cleared | K252190 | Apr 10, 2026 | 270d | Aug 10, 2026 |
M Medela, LLC |
Freestyle Mini Hands-free | Women's Health | 510(k) | Cleared | K253510 | Apr 10, 2026 | 156d | Aug 10, 2026 |
A Ascblue Corporation |
Ascblue (8010) | Surgical | 510(k) | Cleared | K253777 | Apr 10, 2026 | 135d | Aug 10, 2026 |
S Shanghai Draeger Medical Instrument Co., Ltd. |
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065) … | Cardiovascular | 510(k) | Cleared | K252250 | Apr 10, 2026 | 267d | Aug 10, 2026 |
1 1987 Media Limited |
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) | Other | 510(k) | Cleared | K252485 | Apr 10, 2026 | 246d | Aug 10, 2026 |
S Sophysa |
Pressio 3 Multi-parameter Neuromonitoring System | Neurology | 510(k) | Cleared | K252241 | Apr 10, 2026 | 267d | Aug 10, 2026 |
P Protaryx Medical, Inc. |
Protaryx Transseptal Puncture Device (PTX2-001) | Cardiovascular | 510(k) | Cleared | K260839 | Apr 10, 2026 | 28d | Aug 10, 2026 |
O Overjet, Inc. |
Overjet Iris Intelligent Imaging System | Imaging | 510(k) | Cleared | K253930 | Apr 10, 2026 | 122d | Aug 10, 2026 |
A Actis Medical Pty., Ltd. |
SMART Osteotomy System | Orthopedic | 510(k) | Cleared | K260090 | Apr 10, 2026 | 88d | Aug 10, 2026 |
B Becton, Dickinson and Company |
BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Diagnostics | 510(k) | Cleared | K252378 | Apr 10, 2026 | 254d | Aug 10, 2026 |
C Covidien (Part of Medtronic) |
Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads … | Surgical | 510(k) | Cleared | K253657 | Apr 10, 2026 | 141d | Aug 10, 2026 |
P Plasma Surgical, Inc. |
ARION ARC System | Surgical | 510(k) | Cleared | K253917 | Apr 10, 2026 | 123d | Aug 10, 2026 |
D Dk Medical Systems Co., Ltd. |
AeroDR TX c02 | Imaging | 510(k) | Cleared | K253446 | Apr 10, 2026 | 190d | Aug 10, 2026 |
C Cequr SA |
CeQur Simplicity On-Demand Insulin Delivery System | General Hospital | 510(k) | Cleared | K252757 | Apr 10, 2026 | 224d | Aug 10, 2026 |
3 3Shape TRIOS A/S |
TRIOS Dx (R1) | Dental | 510(k) | Cleared | K260082 | Apr 10, 2026 | 88d | Aug 10, 2026 |
B Belport Company, Inc., Gingi-Pak |
Porcelain Etch Gel | Dental | 510(k) | Cleared | K260430 | Apr 10, 2026 | 59d | Aug 10, 2026 |
U University of Utah, Department of Orthopaedics |
CoAptix S System | Orthopedic | 510(k) | Cleared | K252699 | Apr 10, 2026 | 226d | Aug 10, 2026 |
S ShenB Co., Ltd. |
Diacore | Physical Medicine | 510(k) | Cleared | K253926 | Apr 10, 2026 | 123d | Aug 10, 2026 |
I Impulse Dynamics (Usa), Inc. |
GUARDIO/VESTA Charger | Cardiovascular | PMA Supplement | Approved | P180036/S041 | Apr 10, 2026 | 88d | Aug 10, 2026 |
D Depuy, Inc. |
LCS® Total Knee System | Orthopedic | PMA Supplement | Approved (30-day notice) | P830055/S362 | Apr 10, 2026 | 30d | Aug 10, 2026 |
B Boston Scientific |
Lead Port Plug Model 6996 | Cardiovascular | PMA Supplement | Approved | P910077/S197 | Apr 10, 2026 | 65d | Aug 10, 2026 |
B Boston Scientific |
ACUITY X4 Connector Tool Model 4625 AICD Lead Stylets Firm Model 6971 AICD Lead Stylets Soft Model 6972 … | Cardiovascular | PMA Supplement | Approved | P910073/S188 | Apr 10, 2026 | 65d | Aug 10, 2026 |
B Boston Scientific |
Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 Lead Stylets, Long Tapered, Soft Models 5012, 5013 … | Cardiovascular | PMA Supplement | Approved | P150012/S181 | Apr 10, 2026 | 65d | Aug 10, 2026 |
M Mobia Medical, Inc. |
Vivistim® System | Physical Medicine | PMA Supplement | Approved (30-day notice) | P210007/S013 | Apr 10, 2026 | 29d | Aug 10, 2026 |
B Boston Scientific |
Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037 … | Cardiovascular | PMA Supplement | Approved | P960004/S114 | Apr 10, 2026 | 65d | Aug 10, 2026 |
B Boston Scientific Corporation |
TheraSphere | Imaging | PMA Supplement | Approved | P200029/S012 | Apr 10, 2026 | 30d | Aug 10, 2026 |
B Boston Scientific |
Fixation Tool Model 6616 | Cardiovascular | PMA Supplement | Approved | P960006/S058 | Apr 10, 2026 | 65d | Aug 10, 2026 |
M Medtronic |
Heartware Ventricular Assist System | Cardiovascular | PMA Supplement | Approved | P100047/S223 | Apr 10, 2026 | 395d | Aug 10, 2026 |
E Edwards Lifesciences, LLC |
Edwards EVOQUE Tricuspid Valve Replacement System | Cardiovascular | PMA Supplement | Approved | P230013/S025 | Apr 10, 2026 | 30d | Aug 10, 2026 |
Z Zoll Circulation, Inc. |
TherOx Downstream System | Cardiovascular | PMA Supplement | Approved | P170027/S018 | Apr 10, 2026 | 395d | Aug 10, 2026 |
B Boston Scientific |
Vein Pick Model 6541 | Cardiovascular | PMA Supplement | Approved | P830060/S092 | Apr 10, 2026 | 65d | Aug 10, 2026 |
O Organox Limited |
OrganOx metra® System | Other | PMA Supplement | Approved | P200035/S036 | Apr 10, 2026 | 28d | Aug 10, 2026 |
B Boston Scientific |
Wrench Kit Model 6501 | Cardiovascular | PMA Supplement | Approved | P930035/S036 | Apr 10, 2026 | 65d | Aug 10, 2026 |
A AutoGenomics, Inc. |
AvertD and AvertD Buccal Sample Collection Kit | Other | PMA Supplement | Approved | P230032/S004 | Apr 10, 2026 | 91d | Aug 10, 2026 |
D DePuy Orthopaedics, Inc. |
Ceramax Ceramic Hip System | Orthopedic | PMA Supplement | Approved (30-day notice) | P070026/S124 | Apr 10, 2026 | 30d | Aug 10, 2026 |
B Boston Scientific Corp |
Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742 … | Cardiovascular | PMA Supplement | Approved | P010012/S604 | Apr 10, 2026 | 65d | Aug 10, 2026 |
C CG Bio Co., Ltd. |
Easymade-Ti | Neurology | 510(k) | Cleared | K252251 | Apr 9, 2026 | 265d | Aug 10, 2026 |
S Shandong Huge Dental Material Corporation |
Eternal Art Porcelain Powders | Dental | 510(k) | Cleared | K260067 | Apr 9, 2026 | 90d | Aug 10, 2026 |
R Ray Co., Ltd. |
Rct800 | Imaging | 510(k) | Cleared | K260462 | Apr 9, 2026 | 56d | Aug 10, 2026 |
K KLISBio S.r.l. |
SILKBridge | Neurology | 510(k) | Cleared | K260245 | Apr 9, 2026 | 72d | Aug 10, 2026 |
A Anhui Happiness Workshop Instruments Co., Ltd. |
Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | Other | 510(k) | Cleared | K252929 | Apr 9, 2026 | 206d | Aug 10, 2026 |
S Shanghai Apolo Medical Technology Co., Ltd. |
Picosecond Nd:YAG Laser Systems (Model: HS-298) | Surgical | 510(k) | Cleared | K260017 | Apr 9, 2026 | 94d | Aug 10, 2026 |
I International Life Sciences |
Artelon Convenience Kits | Surgical | 510(k) | Cleared | K260317 | Apr 9, 2026 | 69d | Aug 10, 2026 |
S Spineart SA |
SPINEART Navigation Instrument System | Neurology | 510(k) | Cleared | K254158 | Apr 9, 2026 | 108d | Aug 10, 2026 |
C Checkcells, Inc. |
Seaman Pro/Seaman | Diagnostics | 510(k) | Cleared | K252228 | Apr 9, 2026 | 267d | Aug 10, 2026 |
M Maduro Medical, Inc. |
Radical 6F Access Catheter | Cardiovascular | 510(k) | Cleared | K253975 | Apr 9, 2026 | 119d | Aug 10, 2026 |
R Rivanna Medical, Inc. |
Accuro XV | Imaging | 510(k) | Cleared | K254021 | Apr 9, 2026 | 114d | Aug 10, 2026 |
Z Zest Anchors, LLC |
LOCATOR® Angled Abutment | Dental | 510(k) | Cleared | K260555 | Apr 9, 2026 | 50d | Aug 10, 2026 |
M Medtronic, Inc. |
Avalus Bioprosthesis | Cardiovascular | PMA Supplement | Approved (30-day notice) | P170006/S043 | Apr 9, 2026 | 28d | Aug 10, 2026 |
S Synergy Spine Solutions, Inc. |
Synergy Disc | Orthopedic | PMA Supplement | Approved | P250028/S001 | Apr 9, 2026 | 27d | Aug 10, 2026 |
E Ev3 Neurovascular |
Apollo Onyx Delivery Micro Catheter | Neurology | PMA Supplement | Approved (30-day notice) | P030004/S041 | Apr 9, 2026 | 27d | Aug 10, 2026 |
N Novocure, GmbH |
Optune HFE Transducer Array Soft Part Components | Neurology | PMA Supplement | Approved (30-day notice) | P100034/S044 | Apr 9, 2026 | 30d | Aug 10, 2026 |
E Edwards Lifesciences, LLC |
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | Cardiovascular | PMA Supplement | Approved | P200015/S072 | Apr 9, 2026 | 90d | Aug 10, 2026 |
A Abbott Medical |
FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110016/S093 | Apr 9, 2026 | 13d | Aug 10, 2026 |
M Medtronic, Inc. |
Melody Transcatheter Pulmonary Valve | Cardiovascular | PMA Supplement | Approved | P140017/S034 | Apr 9, 2026 | 92d | Aug 10, 2026 |
A Advanced Bionics |
HiResolution Bionic Ear System Ultra and Ultra 3D Thin PCB | Other | PMA Supplement | Approved (30-day notice) | P960058/S174 | Apr 9, 2026 | 30d | Aug 10, 2026 |
E Edwards Lifesciences, LLC |
Sapien 3 Transcatheter Heart Valve And Accessories | Cardiovascular | PMA Supplement | Approved | P140031/S198 | Apr 9, 2026 | 90d | Aug 10, 2026 |
B Boston Scientific Corp |
Rotablator; ROTAPRO Rotational Atherectomy Systems | Cardiovascular | PMA Supplement | Approved (30-day notice) | P900056/S224 | Apr 9, 2026 | 28d | Aug 10, 2026 |
A Asahi Kasei Medical Co., Ltd. |
Plasmaflo OP-05 W(A) | Other | PMA Supplement | Approved (30-day notice) | P820033/S019 | Apr 9, 2026 | 27d | Aug 10, 2026 |
S Seikagaku Corp. |
Gel-One | Orthopedic | PMA Supplement | Approved (30-day notice) | P080020/S055 | Apr 9, 2026 | 28d | Aug 10, 2026 |
W W. L. Gore & Associates, Inc. |
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P230023/S011 | Apr 9, 2026 | 28d | Aug 10, 2026 |
C CooperVision, Inc. |
Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric … | Ophthalmic | PMA Supplement | Approved (30-day notice) | P080011/S200 | Apr 9, 2026 | 16d | Aug 10, 2026 |
B Boston Scientific |
OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160) … | Cardiovascular | 510(k) | Cleared | K260816 | Apr 8, 2026 | 26d | Aug 10, 2026 |
M Modular Medical |
Pivot Insulin Delivery System | General Hospital | 510(k) | Cleared | K253534 | Apr 8, 2026 | 146d | Aug 10, 2026 |
S Shenzhen TPH Technology Co., Ltd. |
Wearable Breast Pump (Model S21A) | Women's Health | 510(k) | Cleared | K260033 | Apr 8, 2026 | 92d | Aug 10, 2026 |
S Scopix , Ltd. |
TL-10 Laparoscopic Scope Cleaner | Other | 510(k) | Cleared | K260089 | Apr 8, 2026 | 86d | Aug 10, 2026 |
T Tenon Medical |
CATAMARAN SI Joint Fusion System | Orthopedic | 510(k) | Cleared | K260477 | Apr 8, 2026 | 55d | Aug 10, 2026 |
S Shenzhen Root Innovation Technology Co., Ltd. |
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A … | Women's Health | 510(k) | Cleared | K254258 | Apr 8, 2026 | 100d | Aug 10, 2026 |
M MacroLux Medical Technology Co., Ltd. |
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | Other | 510(k) | Cleared | K260420 | Apr 8, 2026 | 58d | Aug 10, 2026 |
H Hangzhou AGS MedTech Co., Ltd. |
Hemoclip | Other | 510(k) | Cleared | K252270 | Apr 8, 2026 | 261d | Aug 10, 2026 |
S STERIS Corporation |
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700 … | General Hospital | 510(k) | Cleared | K251666 | Apr 8, 2026 | 313d | Aug 10, 2026 |
S STERIS Corporation |
Celerity 5 HP Biological Indicator (LCB052) | General Hospital | 510(k) | Cleared | K260766 | Apr 8, 2026 | 30d | Aug 10, 2026 |
C CMT Health PTE., Ltd. |
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B) … | Other | 510(k) | Cleared | K253268 | Apr 8, 2026 | 191d | Aug 10, 2026 |
C Changzhou Sifary Medical Technology Co., Ltd. |
Apex Locator (FindPex) | Other | 510(k) | Cleared | K252224 | Apr 8, 2026 | 266d | Aug 10, 2026 |
S Suzhou Shenyun Medical Equipment Co., Ltd. |
Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Other | 510(k) | Cleared | K260197 | Apr 8, 2026 | 76d | Aug 10, 2026 |
R Resmed Corp |
myAir | Anesthesiology | 510(k) | Cleared | K251889 | Apr 8, 2026 | 292d | Aug 10, 2026 |
M Medtronic Vascular, Inc. |
Abre Venous Self-expanding Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200026/S017 | Apr 8, 2026 | 9d | Aug 10, 2026 |
E Empirical Spine, Inc. |
LimiFlex Dynamic Sagittal Tether | Orthopedic | PMA Supplement | Approved | P220031/S001 | Apr 8, 2026 | 27d | Aug 10, 2026 |
G Glaukos Corporation |
iStent® Trabecular Micro-Bypass Stent System | Ophthalmic | PMA Supplement | Approved | P080030/S027 | Apr 8, 2026 | 71d | Aug 10, 2026 |
B Beijing OrionStar Technology Co., Ltd. |
Power Wheelchair (OS-R-M01S) | Physical Medicine | 510(k) | Cleared | K253952 | Apr 7, 2026 | 118d | Aug 10, 2026 |
B Basic Medical Technology, Inc. |
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | General Hospital | 510(k) | Cleared | K260860 | Apr 7, 2026 | 22d | Aug 10, 2026 |
S Shenzhen Root Innovation Technology Co., Ltd. |
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C … | Women's Health | 510(k) | Cleared | K253946 | Apr 7, 2026 | 118d | Aug 10, 2026 |
A Anumana, Inc. |
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Cardiovascular | 510(k) | Cleared | K253801 | Apr 7, 2026 | 130d | Aug 10, 2026 |
H Hangzhou Tappa Medical Technology Co., Ltd. |
Warming System | Cardiovascular | 510(k) | Cleared | K252861 | Apr 7, 2026 | 210d | Aug 10, 2026 |
C Cogentix Medical, Inc. |
PrimeSight UltraView System | Other | 510(k) | Cleared | K253905 | Apr 7, 2026 | 123d | Aug 10, 2026 |
I InnovaCorium, Inc. |
IWD-Gel | Other | 510(k) | Cleared | K254191 | Apr 7, 2026 | 105d | Aug 10, 2026 |
C CenterPoint Systems, LLC |
AuST Steerable Sheath | Cardiovascular | 510(k) | Cleared | K260942 | Apr 7, 2026 | 18d | Aug 10, 2026 |
R Roche Diagnostics |
Elecsys Anti-HAV IgM | Diagnostics | 510(k) | Cleared | K260048 | Apr 7, 2026 | 90d | Aug 10, 2026 |
R Roche Diagnostics |
Elecsys Anti-HBc IgM | Diagnostics | 510(k) | Cleared | K260049 | Apr 7, 2026 | 90d | Aug 10, 2026 |
S Shanghai MicroPort Medical (Group) Co., Ltd. |
Firefighter Pro PTCA Balloon Catheter | Cardiovascular | 510(k) | Cleared | K252116 | Apr 7, 2026 | 274d | Aug 10, 2026 |
Z Zhejiang shuyou Surgical Instrument Co., Ltd. |
Multifunctional Operational Dissectors (Electrosurgical Pencils) … | Surgical | 510(k) | Cleared | K260466 | Apr 7, 2026 | 54d | Aug 10, 2026 |
B Belkin Vision, Ltd. |
Voyager DSLT (430840610) | Ophthalmic | 510(k) | Cleared | K252979 | Apr 7, 2026 | 202d | Aug 10, 2026 |
R Roche Diagnostics |
Elecsys Anti-HBc II | Diagnostics | 510(k) | Cleared | K260046 | Apr 7, 2026 | 90d | Aug 10, 2026 |
A Abiomed, Inc. |
Impella 5.5 with Smart Assist | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140003/S137 | Apr 7, 2026 | 29d | Aug 10, 2026 |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved (30-day notice) | P180046/S109 | Apr 7, 2026 | 25d | Aug 10, 2026 |
C Cerapedics, Inc. |
PearlMatrix Peptide Enhanced Bone Graft | Orthopedic | PMA Supplement | Approved (30-day notice) | P240001/S002 | Apr 7, 2026 | 6d | Aug 10, 2026 |
W W. L. Gore & Associates, Inc. |
GORE® VIABAHN® FORTEGRA Venous Stent | Cardiovascular | PMA Supplement | Approved | P250017/S001 | Apr 7, 2026 | 76d | Aug 10, 2026 |
M Medtronic |
HeartWare HVAD System | Cardiovascular | PMA Supplement | Approved | P100047/S235 | Apr 7, 2026 | 137d | Aug 10, 2026 |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved (30-day notice) | P190006/S109 | Apr 7, 2026 | 25d | Aug 10, 2026 |
C Cerapedics, LLC |
i-FACTOR® Peptide Enhanced Graft Substitute | Orthopedic | PMA Supplement | Approved (30-day notice) | P140019/S013 | Apr 7, 2026 | 6d | Aug 10, 2026 |
T Teoxane S.A. |
Rha 2, Rha 3, Rha 4 | Surgical | PMA Supplement | Approved | P170002/S041 | Apr 7, 2026 | 627d | Aug 10, 2026 |
S Smith & Nephew, Inc. |
AETOS Shoulder System - CONCELOC Glenoids | Orthopedic | 510(k) | Cleared | K254084 | Apr 6, 2026 | 109d | Aug 10, 2026 |
E Esaote, S.p.A. |
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Imaging | 510(k) | Cleared | K253288 | Apr 6, 2026 | 189d | Aug 10, 2026 |
Z Zoll Respicardia, Inc. |
VANES Delivery System (VDS) | Cardiovascular | 510(k) | Cleared | K260459 | Apr 6, 2026 | 54d | Aug 10, 2026 |
P Prosomnus Sleep Technologies |
ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Dental | 510(k) | Cleared | K252765 | Apr 6, 2026 | 220d | Aug 10, 2026 |
R Ricoh 3D For Healthcare, LLC |
Ricoh 3D for Healthcare Bolus | Imaging | 510(k) | Cleared | K253025 | Apr 6, 2026 | 199d | Aug 10, 2026 |
Z Zhuhai Pusen Medical Technology Co., Ltd. |
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Other | 510(k) | Cleared | K260521 | Apr 6, 2026 | 48d | Aug 10, 2026 |
H Hironic Co., Ltd. |
SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Surgical | 510(k) | Cleared | K260397 | Apr 6, 2026 | 59d | Aug 10, 2026 |
F Fujifilm Corporation |
APERTO Lucent MRI System | Imaging | 510(k) | Cleared | K253862 | Apr 6, 2026 | 124d | Aug 10, 2026 |
Y YAMAHACHI DENTAL MFG., Co. |
Glossy Coat (15Ml) | Dental | 510(k) | Cleared | K254091 | Apr 6, 2026 | 108d | Aug 10, 2026 |
V Virility Medical , Ltd. |
in2 Smart (in2S) | Other | 510(k) | Cleared | K252809 | Apr 6, 2026 | 215d | Aug 10, 2026 |
A Aidite (Qinhuangdao) Technology Co., Ltd. |
Light-curing Coloring Materials (ALCM) | Dental | 510(k) | Cleared | K253036 | Apr 6, 2026 | 196d | Aug 10, 2026 |
U Uzinmedicare Co., Ltd. |
SPECTRA Wearable 2 | Women's Health | 510(k) | Cleared | K250208 | Apr 6, 2026 | 437d | Aug 10, 2026 |
S Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
SV70 Ventilator (SV70) | Anesthesiology | 510(k) | Cleared | K252182 | Apr 6, 2026 | 269d | Aug 10, 2026 |
M MED-EL Elektromedizinische Geräte GmbH |
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719) … | Other | 510(k) | Cleared | K260720 | Apr 3, 2026 | 29d | Aug 3, 2026 |
C Cixi Ruihong Electric Appliance Co., Ltd. |
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Women's Health | 510(k) | Cleared | K252744 | Apr 3, 2026 | 217d | Aug 3, 2026 |
S Shanghai United Imaging Healthcare Co., Ltd. |
uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) … | Imaging | 510(k) | Cleared | K260524 | Apr 3, 2026 | 45d | Aug 3, 2026 |
A Automated Imaging Diagnostics, LLC |
neuropacs | Neurology | De Novo | Granted | DEN240071 | Apr 3, 2026 | 485d | Aug 3, 2026 |
N Newpong Co., Ltd. |
Lssa (Np-200) | Surgical | 510(k) | Cleared | K252495 | Apr 3, 2026 | 238d | Aug 3, 2026 |
H Hyalex Orthopaedics, Inc. |
HYALEX® MTP Hemiarthroplasty Implant | Orthopedic | 510(k) | Cleared | K250074 | Apr 3, 2026 | 448d | Aug 3, 2026 |
S Stryker Corporation (Tornier, S.A.S.) |
Blueprint Patient-Specific Instrumentation | Orthopedic | 510(k) | Cleared | K253674 | Apr 3, 2026 | 133d | Aug 3, 2026 |
T Tyber Medical, LLC |
Tyber Medical Trauma Screw | Orthopedic | 510(k) | Cleared | K253042 | Apr 3, 2026 | 193d | Aug 3, 2026 |
C Ceribell, Inc. |
Ceribell Brain Monitor Headband | Neurology | 510(k) | Cleared | K260363 | Apr 3, 2026 | 58d | Aug 3, 2026 |
Z Zhongshan A&J Medical Equipment Co., Ltd. |
Electric Wheelchair (AL-208S-063) | Physical Medicine | 510(k) | Cleared | K253340 | Apr 3, 2026 | 185d | Aug 3, 2026 |
M Mirco-Tech (Nanjing) Co., Ltd. |
Single-use Video Scope; PB Digital Controller | Other | 510(k) | Cleared | K254153 | Apr 3, 2026 | 102d | Aug 3, 2026 |
E Etiometry, Inc. |
Etiometry Platform | Cardiovascular | 510(k) | Cleared | K254066 | Apr 3, 2026 | 106d | Aug 3, 2026 |
R Radformation, Inc. |
ClearCheck (RADCC V2.7) | Imaging | 510(k) | Cleared | K253962 | Apr 3, 2026 | 113d | Aug 3, 2026 |
Z Zhejiang Soudon Medical Technology Co., Ltd. |
Disposable Stone Extraction Basket | Other | 510(k) | Cleared | K253056 | Apr 3, 2026 | 193d | Aug 3, 2026 |
S S.M.A.I.O |
KHEIRON® Spinal Fixation System, including patient specific K-ROD | Orthopedic | 510(k) | Cleared | K260786 | Apr 3, 2026 | 24d | Aug 3, 2026 |
C Chengdu Cryo-Push Medical Technology Co.,Ltd |
Hot and Cold Compression System (A02-C-032) | Physical Medicine | 510(k) | Cleared | K252386 | Apr 3, 2026 | 246d | Aug 3, 2026 |
M MED-EL Elektromedizinische Geräte GmbH |
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691) … | Other | 510(k) | Cleared | K260719 | Apr 3, 2026 | 29d | Aug 3, 2026 |
M Magentiq Eye, Ltd. |
Magentiq-Colo (Me-Apds) | Other | 510(k) | Cleared | K260724 | Apr 3, 2026 | 29d | Aug 3, 2026 |
M MED-EL Elektromedizinische Geräte GmbH |
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671) … | Other | 510(k) | Cleared | K260718 | Apr 3, 2026 | 29d | Aug 3, 2026 |
T TW Medical |
Life Saving Tourniquet | Cardiovascular | 510(k) | Cleared | K254060 | Apr 3, 2026 | 107d | Aug 3, 2026 |
M Medtronic Neuromodulation |
Master Intellis , Vanta and Inceptiv Spinal Cord Stimulation Systems (SCS Implantable Neurostimulators … | Neurology | PMA Supplement | Approved (30-day notice) | P840001/S621 | Apr 3, 2026 | 25d | Aug 3, 2026 |
A Abbott Medical |
AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201) | Cardiovascular | PMA Supplement | Approved | P150035/S036 | Apr 3, 2026 | 73d | Aug 3, 2026 |
M Medtronic Neuromodulation |
InterStim Therapy System, Verify Evaluation System (SNS Urinary Implantable Neurostimulators 97800, 97810) | Other | PMA Supplement | Approved (30-day notice) | P970004/S447 | Apr 3, 2026 | 25d | Aug 3, 2026 |
M Medtronic, Inc. |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense | Neurology | PMA Supplement | Approved (30-day notice) | P960009/S532 | Apr 3, 2026 | 25d | Aug 3, 2026 |
N Neuspera Medical, Inc. |
Neuspera Sacral Neuromodulation (SNM) System | Other | PMA Supplement | Approved (30-day notice) | P240031/S004 | Apr 3, 2026 | 29d | Aug 3, 2026 |
M Medtronic Neuromodulation |
Altaviva | Other | PMA Supplement | Approved (30-day notice) | P240011/S012 | Apr 3, 2026 | 25d | Aug 3, 2026 |
M Medtronic Neuromodulation |
InterStim Therapy System, Verify Evaluation System (SNS Bowel Implantable Neurostimulators 97800, 97810) | Other | PMA Supplement | Approved (30-day notice) | P080025/S342 | Apr 3, 2026 | 25d | Aug 3, 2026 |
B Becton Dickinson Infusion Therapy Systems, Inc. |
BD Insyte IV Catheter | General Hospital | 510(k) | Cleared | K252137 | Apr 2, 2026 | 268d | Aug 3, 2026 |
E El.En S.P.A. |
Specchio | Surgical | 510(k) | Cleared | K260647 | Apr 2, 2026 | 34d | Aug 3, 2026 |
M Miracell Co., Ltd. |
SMART M-CELL Bone Marrow Concentration System | Diagnostics | 510(k) | Cleared | K250518 | Apr 2, 2026 | 405d | Aug 3, 2026 |
I Icu Medical, Inc. |
LifeShield Infusion Safety Software Suite | General Hospital | 510(k) | Cleared | K252130 | Apr 2, 2026 | 269d | Aug 3, 2026 |
M Miracell Co., Ltd. |
SMART M-CELL PRP Concentration System | Diagnostics | 510(k) | Cleared | K250516 | Apr 2, 2026 | 405d | Aug 3, 2026 |
S Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics |
Tahoe Unicondylar Knee System with TiNbN Overcoat | Orthopedic | 510(k) | Cleared | K260796 | Apr 2, 2026 | 22d | Aug 3, 2026 |
X Xuzhou Yongkang Electronic Science Technology Co., Ltd. |
Wireless Probe Type Ultrasound Scanner | Imaging | 510(k) | Cleared | K252709 | Apr 2, 2026 | 218d | Aug 3, 2026 |
M Medical Brands Laboratories B.V. |
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Surgical | 510(k) | Cleared | K252198 | Apr 2, 2026 | 262d | Aug 3, 2026 |
C Chengdu Cryo-Push Medical Technology Co.,Ltd |
Cryopush Cold Compression Device (A02-P-001) | Physical Medicine | 510(k) | Cleared | K253076 | Apr 2, 2026 | 191d | Aug 3, 2026 |
V Verge Medical, Inc. |
FLASH Flex Aorto-Ostial Angioplasty System | Cardiovascular | 510(k) | Cleared | K254022 | Apr 2, 2026 | 107d | Aug 3, 2026 |
B Becton, Dickinson and Company |
Onclarity Self-Collection Kit | Diagnostics | 510(k) | Cleared | K260184 | Apr 2, 2026 | 71d | Aug 3, 2026 |
R Roche Diagnostics |
Tina-quant Cardiac high sensitivity CRP III | Diagnostics | 510(k) | Cleared | K260026 | Apr 2, 2026 | 87d | Aug 3, 2026 |
J Jeil Medical Corporation |
Leforte MMF System | Dental | 510(k) | Cleared | K252246 | Apr 2, 2026 | 258d | Aug 3, 2026 |
B Beijing L&Z Medical Technology Development Co., Ltd. |
Disposable Infusion Bag for Parenteral Nutrition | General Hospital | 510(k) | Cleared | K252079 | Apr 2, 2026 | 274d | Aug 3, 2026 |
G Genoray Co., Ltd. |
Belliger Ace | Imaging | 510(k) | Cleared | K252229 | Apr 2, 2026 | 260d | Aug 3, 2026 |
E Euclid Vision Corporation |
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon … | Ophthalmic | PMA Supplement | Approved (30-day notice) | P040029/S026 | Apr 2, 2026 | 16d | Aug 3, 2026 |
M Medtronic, Inc. |
Sphere-9 Catheter; Tubing Set; Extension Cable | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240013/S023 | Apr 2, 2026 | 28d | Aug 3, 2026 |
B Boston Scientific Corp |
EPIC Self-Expanding Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110035/S075 | Apr 2, 2026 | 27d | Aug 3, 2026 |
E Endospan , Ltd. |
NEXUS Aortic Arch Stent Graft System | Cardiovascular | PMA | Approved | P250033 | Apr 2, 2026 | 223d | Aug 3, 2026 |
B Becton, Dickinson and Company |
BD Onclarity HPV Assay | Diagnostics | PMA Supplement | Approved | P160037/S024 | Apr 2, 2026 | 245d | Aug 3, 2026 |
B Biotronik, Inc. |
Solia CSP S Leads | Cardiovascular | PMA Supplement | Approved | P950037/S288 | Apr 2, 2026 | 30d | Aug 3, 2026 |
B Becton, Dickinson and Company |
BD Onclarity HPV Assay | Diagnostics | PMA Supplement | Approved | P160037/S025 | Apr 2, 2026 | 176d | Aug 3, 2026 |
I Instylla, Inc. |
Embrace Hydrogel Embolic System (HES) | Cardiovascular | PMA Supplement | Approved | P250003/S005 | Apr 2, 2026 | 51d | Aug 3, 2026 |
A Abbott Medical |
HeartMate 3 Left Ventricular Assist System (LVAS) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160054/S124 | Apr 2, 2026 | 29d | Aug 3, 2026 |
S Shenzhen AOJ Medical Technology Co., Ltd. |
Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H … | Cardiovascular | 510(k) | Cleared | K260276 | Apr 1, 2026 | 62d | Aug 3, 2026 |
C Convatec Limited |
GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Other | 510(k) | Cleared | K252943 | Apr 1, 2026 | 198d | Aug 3, 2026 |
P Prana Surgical |
Prana System | Surgical | 510(k) | Cleared | K253405 | Apr 1, 2026 | 183d | Aug 3, 2026 |
P Poly Medicure Limited |
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm … | General Hospital | 510(k) | Cleared | K252513 | Apr 1, 2026 | 233d | Aug 3, 2026 |
H Hudi Pharma Srl |
Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Women's Health | 510(k) | Cleared | K260007 | Apr 1, 2026 | 89d | Aug 3, 2026 |
S Shenzhen RF Tech Co., Ltd. |
GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only … | Imaging | 510(k) | Cleared | K252876 | Apr 1, 2026 | 203d | Aug 3, 2026 |
N Nvision Biomedical Technologies, Inc. |
enHAnce PEEK Bunion System | Orthopedic | 510(k) | Cleared | K253718 | Apr 1, 2026 | 128d | Aug 3, 2026 |
S Shenzhen HanHan Technology Co., Ltd. |
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Cardiovascular | 510(k) | Cleared | K254225 | Apr 1, 2026 | 93d | Aug 3, 2026 |
S Stereotaxis, Inc. |
Synchrony | Cardiovascular | 510(k) | Cleared | K253473 | Apr 1, 2026 | 173d | Aug 3, 2026 |
S Smart Soft Healthcare AD |
CoLumbo C-Spine | Imaging | 510(k) | Cleared | K254015 | Apr 1, 2026 | 107d | Aug 3, 2026 |
A Apple, Inc. |
Medical Imaging Calibration Feature (MICF) | Imaging | 510(k) | Cleared | K253582 | Apr 1, 2026 | 135d | Aug 3, 2026 |
R Retmap, Inc. |
RM Electrode (RMH 25-01) | Ophthalmic | 510(k) | Cleared | K253586 | Apr 1, 2026 | 135d | Aug 3, 2026 |
O Orthomod, LLC |
Mod-C | Orthopedic | 510(k) | Cleared | K242303 | Apr 1, 2026 | 604d | Aug 3, 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/S132 | Apr 1, 2026 | 27d | Aug 3, 2026 |
P Pramand, LLC |
SpineSeal Spine Sealant | Neurology | PMA Supplement | Approved (30-day notice) | P240027/S005 | Apr 1, 2026 | 29d | Aug 3, 2026 |
B Boston Scientific Corp |
Contak Cd, Easytrak, Livian, Cognis And Acuity Spirial Automatic Implantable Cardiac Resynchronization … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010012/S605 | Apr 1, 2026 | 29d | Aug 3, 2026 |
B Boston Scientific Corp |
Pulsar/Pulsar Max Implantable Pulse Generator System With Consult Software | Cardiovascular | PMA Supplement | Approved (30-day notice) | N970003/S306 | Apr 1, 2026 | 29d | Aug 3, 2026 |
B Boston Scientific |
Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960040/S512 | Apr 1, 2026 | 29d | Aug 3, 2026 |
P Pramand, LLC |
CraniSeal Dural Sealant | Neurology | PMA Supplement | Approved (30-day notice) | P220014/S011 | Apr 1, 2026 | 29d | Aug 3, 2026 |
C Companion Spine France Sas |
DIAM Spinal Stabilization System | Orthopedic | PMA Supplement | Approved | P240043/S001 | Apr 1, 2026 | 62d | Aug 3, 2026 |
M Mobia Medical, Inc. |
Vivistim® Paired VNS System | Physical Medicine | PMA Supplement | Approved (30-day notice) | P210007/S012 | Apr 1, 2026 | 30d | Aug 3, 2026 |
I Instylla, Inc. |
Embrace Hydrogel Embolic System (HES) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250003/S006 | Apr 1, 2026 | 27d | Aug 3, 2026 |
A Abiomed, Inc. |
Impella RP System | Cardiovascular | PMA Supplement | Approved | P170011/S063 | Apr 1, 2026 | 30d | Aug 3, 2026 |
B Biotronik AG |
ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P170030/S061 | Apr 1, 2026 | 29d | Aug 3, 2026 |
G Guardant Health, Inc. |
Shield | Other | PMA Supplement | Approved (30-day notice) | P230009/S015 | Apr 1, 2026 | 26d | Aug 3, 2026 |
T Teoxane S.A. |
RHA® Redensity, RHA® Redensity Mepi, RHA®2 and RHA®2 Mepi, RHA®3 and RHA®3 Mepi … | Surgical | PMA Supplement | Approved (30-day notice) | P170002/S054 | Apr 1, 2026 | 30d | Aug 3, 2026 |
G Guidant Corp. |
Contak Renewal Models H125 And H120 With The Model 2865 Version 1.8 Application Software | Cardiovascular | PMA Supplement | Approved (30-day notice) | P030005/S252 | Apr 1, 2026 | 29d | Aug 3, 2026 |
B Biotronik AG |
PRO-Kinetic Energy Coronary Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160003/S026 | Apr 1, 2026 | 29d | Aug 3, 2026 |
Z Zhenjiang Assure Medical Equipment Co., Ltd. |
K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 … | Physical Medicine | 510(k) | Cleared | K260319 | Mar 31, 2026 | 60d | Aug 3, 2026 |
V VATECH Co., Ltd. |
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | Imaging | 510(k) | Cleared | K260093 | Mar 31, 2026 | 77d | Aug 3, 2026 |
C Carbon Medical Technologies, Inc. |
InjecSURE Injection System | Other | 510(k) | Cleared | K253598 | Mar 31, 2026 | 133d | Aug 3, 2026 |
T Tianjin Huahong Technology Co., Ltd. |
Safety lancet (XXXVII) | Surgical | 510(k) | Cleared | K260191 | Mar 31, 2026 | 68d | Aug 3, 2026 |
S Sanhe Meditech Co., Ltd. |
Nd: YAG Laser Therapy Systems | Surgical | 510(k) | Cleared | K260375 | Mar 31, 2026 | 54d | Aug 3, 2026 |
M Mediott, Inc. |
RW-1 | Imaging | 510(k) | Cleared | K253029 | Mar 31, 2026 | 193d | Aug 3, 2026 |
T Teoxane S.A. |
RHA® Redensity Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi … | Surgical | PMA Supplement | Approved | P170002/S053 | Mar 31, 2026 | 60d | Aug 3, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved | P050052/S162 | Mar 31, 2026 | 678d | Aug 3, 2026 |
C Cordis US Corporation |
Mynx Control Vascular Closure Device (5F, 6F/7F) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P040044/S111 | Mar 31, 2026 | 28d | Aug 3, 2026 |
I Implantcast GmbH |
implantcast Packaging System Update | Orthopedic | 510(k) | Cleared | K260037 | Mar 30, 2026 | 83d | Aug 3, 2026 |
V ViTAA Medical Solutions, Inc. |
AiORTA - Plan v2.0 | Imaging | 510(k) | Cleared | K254207 | Mar 30, 2026 | 91d | Aug 3, 2026 |
S Spectrum Spine |
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Orthopedic | 510(k) | Cleared | K252240 | Mar 30, 2026 | 256d | Aug 3, 2026 |
P Philips Medizin Systeme Böblingen GmbH |
IntelliVue Measurement Rack 6000 (867317) | Cardiovascular | 510(k) | Cleared | K253654 | Mar 30, 2026 | 130d | Aug 3, 2026 |
C Centers for Disease Control and Prevention |
Francisella tularensis Real-time PCR Assay | Diagnostics | 510(k) | Cleared | K260812 | Mar 30, 2026 | 17d | Aug 3, 2026 |
B Baebies, Inc. |
FINDER Flu A&B/SARS-CoV-2 Test | Diagnostics | 510(k) | Cleared | K252269 | Mar 30, 2026 | 252d | Aug 3, 2026 |
A Avatar Medical |
Avatar Medical Vision | Imaging | 510(k) | Cleared | K253950 | Mar 30, 2026 | 110d | Aug 3, 2026 |
M Mayer Laboratories |
Sagami Original 002 Polyurethane Male Condom | Women's Health | 510(k) | Cleared | K252158 | Mar 30, 2026 | 264d | Aug 3, 2026 |
A ArthroCare Corporation |
FLOW FLEXTEND Wand (72290039) | Surgical | 510(k) | Cleared | K254122 | Mar 30, 2026 | 101d | Aug 3, 2026 |
B Bloomden Bioceramics (HuNan) Co., Ltd. |
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Dental | 510(k) | Cleared | K260370 | Mar 30, 2026 | 53d | Aug 3, 2026 |
K Kaneka Pharma America Corp. |
LIPOSORBER® LA-15 System | Other | PMA Supplement | Approved | P910018/S041 | Mar 30, 2026 | 75d | Aug 3, 2026 |
O Organox Limited |
OrganOx metra® System | Other | PMA Supplement | Approved | P200035/S035 | Mar 30, 2026 | 89d | Aug 3, 2026 |
B Biotronik, Inc. |
Amvia-Solvia Pulse Generators Scan Duration Extension | Cardiovascular | PMA Supplement | Approved | P950037/S282 | Mar 30, 2026 | 90d | Aug 3, 2026 |
A Anumana, Inc. |
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Cardiovascular | 510(k) | Cleared | K252360 | Mar 28, 2026 | 242d | Jul 28, 2026 |
S Sanhe Meditech Co., Ltd. |
CO2 Laser System | Surgical | 510(k) | Cleared | K260257 | Mar 28, 2026 | 59d | Jul 28, 2026 |
Z Zhuhai Fitlens Medical Technology Co., Ltd. |
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Ophthalmic | 510(k) | Cleared | K253822 | Mar 27, 2026 | 119d | Jul 28, 2026 |
S Synergy Spine Solutions, Inc. |
Synergy Disc Instruments | Orthopedic | 510(k) | Cleared | K253392 | Mar 27, 2026 | 178d | Jul 28, 2026 |
E Esaote, S.p.A. |
S-scan Open (100001800) | Imaging | 510(k) | Cleared | K260746 | Mar 27, 2026 | 21d | Jul 28, 2026 |
M Medos International SARL |
SYMPHONY Navigation Ready Instruments | Neurology | 510(k) | Cleared | K260240 | Mar 27, 2026 | 60d | Jul 28, 2026 |
P Philips Ultrasound, LLC |
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Imaging | 510(k) | Cleared | K253595 | Mar 27, 2026 | 129d | Jul 28, 2026 |
P Philips Medical Systems Technologies , Ltd. |
Spectral CT Verida Family | Imaging | 510(k) | Cleared | K253649 | Mar 27, 2026 | 127d | Jul 28, 2026 |
N Ningbo Zhishan Medical Technology Co., Ltd. |
Power wheelchair (ZS-EW8026) | Physical Medicine | 510(k) | Cleared | K254206 | Mar 27, 2026 | 88d | Jul 28, 2026 |
A American Medical Endoscopy, Inc. |
Strauss Surgical cystoscope, hysteroscope and accessories Instruments | Other | 510(k) | Cleared | K260271 | Mar 27, 2026 | 58d | Jul 28, 2026 |
A Artiness S.R.L |
ARTICOR planner | Imaging | 510(k) | Cleared | K252195 | Mar 27, 2026 | 256d | Jul 28, 2026 |
C Canon Medical Systems Corporation |
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Imaging | 510(k) | Cleared | K253625 | Mar 27, 2026 | 129d | Jul 28, 2026 |
G GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC |
Automated Aortic Stenosis Software (AutoAS) | Imaging | 510(k) | Cleared | K254161 | Mar 27, 2026 | 95d | Jul 28, 2026 |
V Vy Spine, LLC |
VyPlate Anterior Cervical Plate System | Orthopedic | 510(k) | Cleared | K260697 | Mar 27, 2026 | 23d | Jul 28, 2026 |
A Aventix Medical, Inc. |
AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Surgical | 510(k) | Cleared | K260255 | Mar 27, 2026 | 58d | Jul 28, 2026 |
M Medcad |
MedCAD® AccuStride System | Orthopedic | 510(k) | Cleared | K252064 | Mar 27, 2026 | 269d | Jul 28, 2026 |
B Butterfly Network, Inc. |
Butterfly Gestational Age Tool | Imaging | 510(k) | Cleared | K252148 | Mar 27, 2026 | 261d | Jul 28, 2026 |
F Foshan Dahao Medical Technology Co., Ltd. |
Electric wheelchair | Physical Medicine | 510(k) | Cleared | K253307 | Mar 27, 2026 | 179d | Jul 28, 2026 |
B Boston Scientific Corporation |
Asurys Fluid Management System | Women's Health | 510(k) | Cleared | K251273 | Mar 27, 2026 | 337d | Jul 28, 2026 |
S Surgical Fusion Technologies GmbH |
SF Push-in Anchor | Orthopedic | 510(k) | Cleared | K260294 | Mar 27, 2026 | 57d | Jul 28, 2026 |
M Mim Software, Inc. |
Contour ProtégéAI+ | Imaging | 510(k) | Cleared | K253270 | Mar 27, 2026 | 179d | Jul 28, 2026 |
I Icu Medical, Inc. |
OTTO Disinfecting Cap | General Hospital | 510(k) | Cleared | K252006 | Mar 27, 2026 | 273d | Jul 28, 2026 |
S Streck, LLC |
MDx-Chex for BCP | Diagnostics | 510(k) | Cleared | K260041 | Mar 27, 2026 | 80d | Jul 28, 2026 |
S Samsung Medison Co., Ltd. |
EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System … | Imaging | 510(k) | Cleared | K254099 | Mar 27, 2026 | 98d | Jul 28, 2026 |
S Ss Global |
CyClean Cord | Other | 510(k) | Cleared | K254239 | Mar 27, 2026 | 88d | Jul 28, 2026 |
Y Yurob Rehabilitation Medical Co., Ltd. |
Electrically Powered Wheelchair (Model YC-01) | Physical Medicine | 510(k) | Cleared | K253980 | Mar 27, 2026 | 105d | Jul 28, 2026 |
A Aneuvo |
ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003) … | Physical Medicine | 510(k) | Cleared | K252893 | Mar 27, 2026 | 197d | Jul 28, 2026 |
E ETHICON, Inc. |
STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA … | Surgical | 510(k) | Cleared | K253572 | Mar 27, 2026 | 130d | Jul 28, 2026 |
T Terumo Corporation |
Ryurei | Cardiovascular | 510(k) | Cleared | K252295 | Mar 27, 2026 | 247d | Jul 28, 2026 |
L Lincotek Medical |
SportLinc Syndesmosis Device | Orthopedic | 510(k) | Cleared | K252081 | Mar 27, 2026 | 268d | Jul 28, 2026 |
C Cardiva Medical, Inc. |
VASCADE MVP XL VVCS Model 800-1014XL | Cardiovascular | PMA Supplement | Approved | P120016/S039 | Mar 27, 2026 | 178d | Jul 28, 2026 |
B Biotronik, Inc. |
Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P950037/S287 | Mar 27, 2026 | 28d | Jul 28, 2026 |
A Abbott Medical |
Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P030054/S443 | Mar 27, 2026 | 28d | Jul 28, 2026 |
D Depuy, Inc. |
LCS® Total Knee System | Orthopedic | PMA Supplement | Approved (30-day notice) | P830055/S363 | Mar 27, 2026 | 3d | Jul 28, 2026 |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved | P190006/S100 | Mar 27, 2026 | 206d | Jul 28, 2026 |
M Medtronic, Inc. |
Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010015/S584 | Mar 27, 2026 | 17d | Jul 28, 2026 |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved | P180046/S100 | Mar 27, 2026 | 206d | Jul 28, 2026 |
E EBR Systems, Inc. |
WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240028/S006 | Mar 27, 2026 | 30d | Jul 28, 2026 |
M Medtronic, Inc. |
Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P980035/S838 | Mar 27, 2026 | 17d | Jul 28, 2026 |
M Medtronic, Inc. |
Medtronic CoreValve EnVeo PRO Delivery Catheter System; Medtronic Evolut PRO+ Delivery Catheter System … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P130021/S184 | Mar 27, 2026 | 22d | Jul 28, 2026 |
M Medtronic, Inc. |
Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P980035/S837 | Mar 27, 2026 | 22d | Jul 28, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D | Cardiovascular | PMA Supplement | Approved (30-day notice) | P010031/S921 | Mar 27, 2026 | 17d | Jul 28, 2026 |
M Medtronic Cardiac Rhythm Disease Management |
Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD | Cardiovascular | PMA Supplement | Approved (30-day notice) | P980016/S954 | Mar 27, 2026 | 17d | Jul 28, 2026 |
A Abbott Medical |
Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T) … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P910023/S485 | Mar 27, 2026 | 28d | Jul 28, 2026 |
V Vizaramed, Inc. |
Multiflex Steerable Sheath 17.5F | Cardiovascular | 510(k) | Cleared | K260626 | Mar 26, 2026 | 28d | Jul 28, 2026 |
B Biomerieux |
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | Diagnostics | 510(k) | Cleared | K260281 | Mar 26, 2026 | 56d | Jul 28, 2026 |
S Shenzhen Urion Technology Co., Ltd. |
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus … | Cardiovascular | 510(k) | Cleared | K260273 | Mar 26, 2026 | 56d | Jul 28, 2026 |
S Surgify Medical OY |
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1) … | Neurology | 510(k) | Cleared | K253627 | Mar 26, 2026 | 127d | Jul 28, 2026 |
M Medtronic Navigation, Inc. |
Stealth AXiS Cranial clinical application | Neurology | 510(k) | Cleared | K253379 | Mar 26, 2026 | 177d | Jul 28, 2026 |
B Blue Belt Technologies, Inc. |
Real Intelligence Cori | Neurology | 510(k) | Cleared | K260601 | Mar 26, 2026 | 30d | Jul 28, 2026 |
D Devilbiss Healthcare, LLC |
DeVilbiss 5 Liter Oxygen Concentrator (555) | Anesthesiology | 510(k) | Cleared | K253549 | Mar 26, 2026 | 132d | Jul 28, 2026 |
R Restore Robotics |
Robotic Surgical Instruments - Permanent Cautery Hook (470183) … | Other | 510(k) | Cleared | K252926 | Mar 26, 2026 | 192d | Jul 28, 2026 |
L Lunit, Inc. |
Lunit INSIGHT DBT (V1.2) | Imaging | 510(k) | Cleared | K253796 | Mar 26, 2026 | 118d | Jul 28, 2026 |
A Airs Medical, Inc. |
SwiftMR | Imaging | 510(k) | Cleared | K253775 | Mar 26, 2026 | 120d | Jul 28, 2026 |
M Medinol, Ltd. |
EluNIR Ridaforolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P170008/S062 | Mar 26, 2026 | 30d | Jul 28, 2026 |
B Bolton Medical, Inc. |
TREO® Abdominal Stent-Graft System | Cardiovascular | PMA Supplement | Approved | P190015/S026 | Mar 26, 2026 | 177d | Jul 28, 2026 |
M Medtronic Neuromodulation |
Altaviva | Other | PMA Supplement | Approved | P240011/S011 | Mar 26, 2026 | 30d | Jul 28, 2026 |
A Alphatec Spine, Inc. |
Invictus Bands System | Orthopedic | 510(k) | Cleared | K253615 | Mar 25, 2026 | 127d | Jul 28, 2026 |
S Spinepoint, LLC |
Flex-Z Cervical Cage | Orthopedic | 510(k) | Cleared | K252432 | Mar 25, 2026 | 236d | Jul 28, 2026 |
M Mevion Medical Systems, Inc. |
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Imaging | 510(k) | Cleared | K253406 | Mar 25, 2026 | 176d | Jul 28, 2026 |
A ArthroCare Corporation |
LYNX COBLATION Laryngeal Wand (72290254) | Surgical | 510(k) | Cleared | K253680 | Mar 25, 2026 | 124d | Jul 28, 2026 |
N Nvision Biomedical Technologies, Inc. |
Vortex5 Tailor's Bunion Correction System | Orthopedic | 510(k) | Cleared | K260291 | Mar 25, 2026 | 55d | Jul 28, 2026 |
S Sandstone Medical (Suzhou), Inc. |
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle … | General Hospital | 510(k) | Cleared | K252908 | Mar 25, 2026 | 194d | Jul 28, 2026 |
M Medline Industries, LP |
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit … | Anesthesiology | 510(k) | Cleared | K253322 | Mar 25, 2026 | 176d | Jul 28, 2026 |
S Spectrum Vascular |
Arterial Pressure Monitoring Set/Tray | Cardiovascular | 510(k) | Cleared | K254278 | Mar 25, 2026 | 85d | Jul 28, 2026 |
Z Zhuhai Wesee Meditech Co., Ltd. |
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Other | 510(k) | Cleared | K253184 | Mar 25, 2026 | 180d | Jul 28, 2026 |
L Letus Corporation |
MiraChlor Antimicrobial Wound Solution | Other | 510(k) | Cleared | K252023 | Mar 25, 2026 | 268d | Jul 28, 2026 |
B Bausch and Lomb, Incorporated |
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Ophthalmic | 510(k) | Cleared | K252052 | Mar 25, 2026 | 267d | Jul 28, 2026 |
C Curexo, Inc. |
CUVIS-joint (CJ150) | Neurology | 510(k) | Cleared | K252037 | Mar 25, 2026 | 268d | Jul 28, 2026 |
N Novastep SAS |
Airlock® Ankle Plating System | Orthopedic | 510(k) | Cleared | K260274 | Mar 25, 2026 | 55d | Jul 28, 2026 |
M Medtronic, Inc. |
Symplicity Spyral Renal Denervation Catheter | Cardiovascular | PMA Supplement | Approved (30-day notice) | P220026/S016 | Mar 25, 2026 | 30d | Jul 28, 2026 |
L Lenstec, Inc. |
ClearView 3 IOL | Ophthalmic | PMA Supplement | Approved | P200020/S011 | Mar 25, 2026 | 79d | Jul 28, 2026 |
C Cook Ireland, Ltd. |
Zilver® PTX® Drug-Eluting Peripheral Stent | Cardiovascular | PMA Supplement | Approved (30-day notice) | P100022/S045 | Mar 25, 2026 | 23d | Jul 28, 2026 |
A Abbott Medical |
CardioMEMS HF System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P100045/S088 | Mar 25, 2026 | 30d | Jul 28, 2026 |
M Medtronic Vascular |
Onyx Frontier Zotarolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160043/S090 | Mar 25, 2026 | 30d | Jul 28, 2026 |
B Boston Scientific Corp |
Watchman Left Atrial Appendage (Laa) Closure Technology | Cardiovascular | PMA Supplement | Approved | P130013/S076 | Mar 25, 2026 | 411d | Jul 28, 2026 |
A Abbott Medical |
HeartMate 3 Left Ventricular Assist System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160054/S123 | Mar 25, 2026 | 26d | Jul 28, 2026 |
G GE Medical Systems SCS |
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | Imaging | 510(k) | Cleared | K260087 | Mar 24, 2026 | 71d | Jul 28, 2026 |
A Angiodynamics |
NanoKnife Generator (H78720300351US0) | Surgical | 510(k) | Cleared | K253198 | Mar 24, 2026 | 179d | Jul 28, 2026 |
N Nanjing CareMoving Rehabilitation Equipment Co.,Ltd |
Electric Wheelchair (E201) | Physical Medicine | 510(k) | Cleared | K254012 | Mar 24, 2026 | 99d | Jul 28, 2026 |
B Beckman Coulter, Inc. |
Access BNP II | Diagnostics | 510(k) | Cleared | K252169 | Mar 24, 2026 | 257d | Jul 28, 2026 |
G GE Medical Systems Ultrasound and Primary Care Diagnostics |
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro … | Imaging | 510(k) | Cleared | K260673 | Mar 24, 2026 | 22d | Jul 28, 2026 |
S Shimadzu Corporation |
Trinias | Imaging | 510(k) | Cleared | K252099 | Mar 24, 2026 | 264d | Jul 28, 2026 |
L Lumos Diagnostics, Inc. |
FebriDx Bacterial/Non-bacterial Assay | Diagnostics | 510(k) | Cleared | K260787 | Mar 24, 2026 | 14d | Jul 28, 2026 |
J JLK, Inc. |
Jlk-Ncct | Imaging | 510(k) | Cleared | K252421 | Mar 24, 2026 | 235d | Jul 28, 2026 |
N Nipro Medical Corporation |
Pressone | General Hospital | 510(k) | Cleared | K253047 | Mar 24, 2026 | 183d | Jul 28, 2026 |
A Aap Implantate AG |
LOQTEQ® VA Proximal Humerus Plate 3.5 | Orthopedic | 510(k) | Cleared | K254253 | Mar 24, 2026 | 85d | Jul 28, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved (30-day notice) | P050037/S152 | Mar 24, 2026 | 27d | Jul 28, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved (30-day notice) | P050037/S151 | Mar 24, 2026 | 29d | Jul 28, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved (30-day notice) | P050052/S176 | Mar 24, 2026 | 29d | Jul 28, 2026 |
M Merz North America, Inc. |
P050052 RADIESSE® Injectable Implant; RADIESSE® Hands; RADIESSE® (+) Lidocaine; Jawline indication | Surgical | PMA Supplement | Approved (30-day notice) | P050052/S177 | Mar 24, 2026 | 27d | Jul 28, 2026 |
M Medtronic, Inc. |
Harmony Transcatheter Pulmonary Valve System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200046/S050 | Mar 24, 2026 | 29d | Jul 28, 2026 |
I Intrinsic Therapeutics |
Barricaid® Annular Closure Device | Orthopedic | PMA Supplement | Approved (30-day notice) | P160050/S012 | Mar 24, 2026 | 25d | Jul 28, 2026 |
F Ferrosan Meidcal Devices A/S |
SURGIFOAM® Absorbable Gelatin Sponge | Surgical | PMA Supplement | Approved (30-day notice) | P990004/S079 | Mar 24, 2026 | 25d | Jul 28, 2026 |
G Ge Healthcare Japan Corporation |
True Definition DL | Imaging | 510(k) | Cleared | K253686 | Mar 23, 2026 | 122d | Jul 28, 2026 |
T Threadstone, LLC |
HyperSuture All Green Extension Line | Surgical | 510(k) | Cleared | K254275 | Mar 23, 2026 | 83d | Jul 28, 2026 |
P Philips Healthcare (Suzhou) Co., Ltd. |
CT Rembra RT; CT Areta RT; CT Rembra | Imaging | 510(k) | Cleared | K252992 | Mar 23, 2026 | 186d | Jul 28, 2026 |
S Stabiliz Orthopaedics, Inc. |
QuikFix External Fixator: Knee-Spanning Pack | Orthopedic | 510(k) | Cleared | K260112 | Mar 23, 2026 | 68d | Jul 28, 2026 |
S Skeletal Dynamics, Inc. |
Clavicle Fixation System | Orthopedic | 510(k) | Cleared | K254288 | Mar 23, 2026 | 82d | Jul 28, 2026 |
S Streck |
MDx-Chex for BCN | Diagnostics | 510(k) | Cleared | K254166 | Mar 23, 2026 | 90d | Jul 28, 2026 |
A Adin Dental Implant Systems , Ltd. |
Adin Long Dental Implant System | Dental | 510(k) | Cleared | K252031 | Mar 23, 2026 | 266d | Jul 28, 2026 |
G Guangdong Newdermo Biotech Co., Ltd. |
LED Light Therapy Masks (LumiLips FAC07NA) | Surgical | 510(k) | Cleared | K260202 | Mar 23, 2026 | 59d | Jul 28, 2026 |
A Abbott Medical |
Volt PFA Catheter Sensor Enabled | Cardiovascular | PMA Supplement | Approved | P250022/S001 | Mar 23, 2026 | 90d | Jul 28, 2026 |
M Medtronic Vascular, Inc. |
Protégé GPS Self-Expanding Peripheral Stent System; Protégé RX Carotid Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P060001/S057 | Mar 23, 2026 | 11d | Jul 28, 2026 |
H Highridge Medical, LLC |
Mobi-C® P&F Cervical Disc Prosthesis | Orthopedic | PMA Supplement | Approved (30-day notice) | P110009/S038 | Mar 23, 2026 | 14d | Jul 28, 2026 |
M Medtronic Vascular, Inc. |
Abre Venous Self-expanding Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200026/S016 | Mar 23, 2026 | 11d | Jul 28, 2026 |
I Insightec |
Exablate | Neurology | PMA Supplement | Approved | P150038/S041 | Mar 23, 2026 | 129d | Jul 28, 2026 |
H Highridge Medical, LLC |
Mobi-C® Cervical Disc Prosthesis | Orthopedic | PMA Supplement | Approved (30-day notice) | P110002/S038 | Mar 23, 2026 | 14d | Jul 28, 2026 |
M Medtronic Vascular, Inc. |
EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust … | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110023/S066 | Mar 23, 2026 | 11d | Jul 28, 2026 |
I Icu Medical, Inc. |
ClaveQS Bag | General Hospital | 510(k) | Cleared | K251980 | Mar 20, 2026 | 266d | Jul 28, 2026 |
P Philips Healthcare (Suzhou) Co., Ltd. |
Smart Fit TorsoCardiac 1.5T | Imaging | 510(k) | Cleared | K260519 | Mar 20, 2026 | 31d | Jul 28, 2026 |
N Nox Medical Ehf |
Noxturnal Web | Neurology | 510(k) | Cleared | K260585 | Mar 20, 2026 | 28d | Jul 28, 2026 |
I Instrumentation Laboratory (IL) Co. |
HemosIL Factor V Leiden (APC Resistance V) | Diagnostics | 510(k) | Cleared | K260551 | Mar 20, 2026 | 30d | Jul 28, 2026 |
D Degania Silicone , Ltd. |
Percutaneous Endoscopic Gastrostomy (PEG) Kit | Other | 510(k) | Cleared | K254170 | Mar 20, 2026 | 87d | Jul 28, 2026 |
O Olympus Medical Systems Corporation |
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Other | 510(k) | Cleared | K252050 | Mar 20, 2026 | 262d | Jul 28, 2026 |
S SurGenTec, LLC |
TiLink-L Navigation Instruments | Neurology | 510(k) | Cleared | K253604 | Mar 20, 2026 | 122d | Jul 28, 2026 |
L Liviwell, Inc. |
Livi Device | Women's Health | 510(k) | Cleared | K252005 | Mar 20, 2026 | 266d | Jul 28, 2026 |
N Nexstim Oyj |
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Neurology | 510(k) | Cleared | K252358 | Mar 20, 2026 | 234d | Jul 28, 2026 |
D Dongguan TT Medical, Inc. |
Valvuloplasty Balloon Catheter (ValvuloPro) | Cardiovascular | 510(k) | Cleared | K260437 | Mar 20, 2026 | 37d | Jul 28, 2026 |
E Expanse Medical, Inc. |
FLOWRUNNER Aspiration System | Cardiovascular | 510(k) | Cleared | K254208 | Mar 20, 2026 | 81d | Jul 28, 2026 |
N Nordicneurolab AS |
nordicAudio (1.0) | Imaging | 510(k) | Cleared | K251937 | Mar 20, 2026 | 269d | Jul 28, 2026 |
A Arthrex, Inc. |
Arthrex Humeral Nails | Orthopedic | 510(k) | Cleared | K252016 | Mar 20, 2026 | 266d | Jul 28, 2026 |
H Hangzhou Tappa Medical Technology Co., Ltd. |
Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107) … | Anesthesiology | 510(k) | Cleared | K251950 | Mar 20, 2026 | 268d | Jul 28, 2026 |
V Voco GmbH |
Bifix Veneer LC, Bifix Veneer Try-In | Dental | 510(k) | Cleared | K252606 | Mar 20, 2026 | 214d | Jul 28, 2026 |
N Nexstim Oyj |
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Neurology | 510(k) | Cleared | K253098 | Mar 20, 2026 | 178d | Jul 28, 2026 |
Z ZheJiang J&J Mobility Co., Ltd. |
Electric wheelchair (JJW-7002, JJW-7003) | Physical Medicine | 510(k) | Cleared | K253849 | Mar 20, 2026 | 108d | Jul 28, 2026 |
F FMD Co., Ltd. |
FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 … | Cardiovascular | 510(k) | Cleared | K260544 | Mar 20, 2026 | 30d | Jul 28, 2026 |
G Ge Medical Systems, LLC |
Photonova Spectra, Photonova Spectra Select | Imaging | 510(k) | Cleared | K253520 | Mar 20, 2026 | 128d | Jul 28, 2026 |
D Dental Imaging Technologies Corporation |
NOMAD Pro 3 | Dental | 510(k) | Cleared | K253864 | Mar 20, 2026 | 107d | Jul 28, 2026 |
A Arthrex, Inc. |
Arthrex FiberTak Suture Anchor | Orthopedic | 510(k) | Cleared | K260561 | Mar 20, 2026 | 29d | Jul 28, 2026 |
S Siemens Medical Solutions USA, Inc. |
SOMATOM X.cite; SOMATOM X.ceed | Imaging | 510(k) | Cleared | K253574 | Mar 20, 2026 | 123d | Jul 28, 2026 |
A Abbott Molecular, Inc. |
Abbott RealTime IDH2 | Other | PMA Supplement | Approved (30-day notice) | P170005/S005 | Mar 20, 2026 | 28d | Jul 28, 2026 |
A Abbott Vascular (Idef Technologies Inc) |
Supera Peripheral Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P120020/S036 | Mar 20, 2026 | 28d | Jul 28, 2026 |
M MicroVention, Inc. |
Woven EndoBridge Aneurysm Embolization (WEB) System | Neurology | PMA Supplement | Approved | P170032/S019 | Mar 20, 2026 | 260d | Jul 28, 2026 |
A Abbott Molecular, Inc. |
Abbott RealTime IDH1 | Other | PMA Supplement | Approved (30-day notice) | P170041/S008 | Mar 20, 2026 | 28d | Jul 28, 2026 |
A Abbott Vascular, Inc. |
XACT Carotid Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P040038/S051 | Mar 20, 2026 | 28d | Jul 28, 2026 |
Q Q-Med AB |
Restylane® Contour | Surgical | PMA Supplement | Approved | P140029/S054 | Mar 20, 2026 | 239d | Jul 28, 2026 |
M Medtronic, Inc. |
Sphere-9 Catheter (AFR-00001) | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240013/S021 | Mar 20, 2026 | 30d | Jul 28, 2026 |
C Carl Zeiss Meditec Production, LLC |
Ct Lucia 602; Ct Lucia 202; Ct Lucia 611P; Ct Lucia 621P | Ophthalmic | PMA Supplement | Approved | P100016/S023 | Mar 20, 2026 | 123d | Jul 28, 2026 |
D DiaDent Group International |
Dia-X Sil Bite | Dental | 510(k) | Cleared | K254112 | Mar 19, 2026 | 90d | Jul 28, 2026 |
S St. shine Optical Co., Ltd. |
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens … | Ophthalmic | 510(k) | Cleared | K254269 | Mar 19, 2026 | 79d | Jul 28, 2026 |
R Radformation, Inc. |
AutoContour (RADAC V5) | Imaging | 510(k) | Cleared | K260509 | Mar 19, 2026 | 30d | Jul 28, 2026 |
M Mirco-Tech (Nanjing) Co., Ltd. |
Disposable Distal Cap | Other | 510(k) | Cleared | K253139 | Mar 19, 2026 | 175d | Jul 28, 2026 |
G Geistlich Pharma AG |
Derma-Gide | Other | 510(k) | Cleared | K260532 | Mar 19, 2026 | 30d | Jul 28, 2026 |
N Nipro Medical Corporation |
Elisio-H | Other | 510(k) | Cleared | K260533 | Mar 19, 2026 | 30d | Jul 28, 2026 |
W Wuhan PHOMED Technology Company , Ltd. |
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30 … | Physical Medicine | 510(k) | Cleared | K253965 | Mar 19, 2026 | 98d | Jul 28, 2026 |
L Lake Region Medical |
Enroute 0.014'' Transcarotid Guidewire | Cardiovascular | 510(k) | Cleared | K253746 | Mar 19, 2026 | 114d | Jul 28, 2026 |
L L&K BIOMED Co., Ltd. |
CastleLoc Pectus Bar System | Orthopedic | 510(k) | Cleared | K260448 | Mar 19, 2026 | 36d | Jul 28, 2026 |
V Vy Spine, LLC |
DiversiVy Facet Screw System | Other | 510(k) | Cleared | K253432 | Mar 19, 2026 | 169d | Jul 28, 2026 |
A Arbor Endovascular, LLC |
Willow 24 Guidewire | Cardiovascular | 510(k) | Cleared | K260537 | Mar 19, 2026 | 30d | Jul 28, 2026 |
Y Yamaha Motor Co., Ltd. |
Jwg-1 | Physical Medicine | 510(k) | Cleared | K252101 | Mar 19, 2026 | 259d | Jul 28, 2026 |
S Senseonics, Incorporated |
Eversense® Continuous Glucose Monitoring System | Diagnostics | PMA Supplement | Approved | P160048/S031 | Mar 19, 2026 | 24d | Jul 28, 2026 |
T The Spectranetics Corp. |
Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon | Cardiovascular | PMA Supplement | Approved (30-day notice) | P160049/S028 | Mar 19, 2026 | 21d | Jul 28, 2026 |
P Proverum, Ltd. |
ProVee System for BPH | Other | PMA Supplement | Approved | P250011/S001 | Mar 19, 2026 | 29d | Jul 28, 2026 |
A Agilent Technologies, Inc. |
PD-L1 IHC 22C3 pharmDx | Diagnostics | PMA Supplement | Approved | P150013/S031 | Mar 19, 2026 | 234d | Jul 28, 2026 |
M Medtronic Minimed, Inc. |
Simplera Sync Sensor | Diagnostics | PMA Supplement | Approved (30-day notice) | P160017/S136 | Mar 19, 2026 | 27d | Jul 28, 2026 |
A Abbott Medical |
Amplatzer Amulet Left Atrial Appendage Occluder | Cardiovascular | PMA Supplement | Approved (30-day notice) | P200049/S017 | Mar 19, 2026 | 30d | Jul 28, 2026 |
M Medtronic Sofamor Danek USA, Inc. |
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Orthopedic | PMA Supplement | Approved (30-day notice) | P000058/S098 | Mar 19, 2026 | 30d | Jul 28, 2026 |
M Medtronic, Inc. |
INFUSE® Bone Graft | Dental | PMA Supplement | Approved (30-day notice) | P050053/S068 | Mar 19, 2026 | 30d | Jul 28, 2026 |
M Medtronic Sofamor Danek USA, Inc. |
INFUSE® Bone Graft | Orthopedic | PMA Supplement | Approved (30-day notice) | P000054/S077 | Mar 19, 2026 | 30d | Jul 28, 2026 |
M Medtronic Minimed, Inc. |
Simplera Sync Sensor | Diagnostics | PMA Supplement | Approved (30-day notice) | P250012/S009 | Mar 19, 2026 | 27d | Jul 28, 2026 |
V Varian Medical Systems, Inc. |
syngo.via RT Image Suite VC10 | Imaging | 510(k) | Cleared | K252304 | Mar 18, 2026 | 237d | Jul 28, 2026 |
M MedShape, Inc. |
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | Orthopedic | 510(k) | Cleared | K254110 | Mar 18, 2026 | 89d | Jul 28, 2026 |
M MiRus, LLC |
EUROPA Posterior Cervical Fusion Navigated Instruments | Neurology | 510(k) | Cleared | K253444 | Mar 18, 2026 | 167d | Jul 28, 2026 |
S Sangi Co., Ltd. |
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Dental | 510(k) | Cleared | K260830 | Mar 18, 2026 | 5d | Jul 28, 2026 |
L LimFlow, Inc. |
LimFlow Vector | Cardiovascular | 510(k) | Cleared | K260188 | Mar 18, 2026 | 55d | Jul 28, 2026 |
C Carl Zeiss Vision GmbH |
Visuref 600 | Ophthalmic | 510(k) | Cleared | K253834 | Mar 18, 2026 | 107d | Jul 28, 2026 |
N Ningbo Medsun Medical Co., Ltd. |
Safety Pen Needle | General Hospital | 510(k) | Cleared | K253622 | Mar 18, 2026 | 120d | Jul 28, 2026 |
F Fusion Orthopedics USA, LLC |
Fusion FibFix Nail | Orthopedic | 510(k) | Cleared | K252961 | Mar 18, 2026 | 183d | Jul 28, 2026 |
O O&M Halyard, Inc. |
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops … | Surgical | 510(k) | Cleared | K251967 | Mar 18, 2026 | 265d | Jul 28, 2026 |
V Vision Rt, Ltd. |
AlignRT Plus (8.0) | Imaging | 510(k) | Cleared | K253012 | Mar 18, 2026 | 180d | Jul 28, 2026 |
B Boston Scientific |
INGEVITY+ Pace / Sense Lead Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm … | Cardiovascular | PMA Supplement | Approved | P150012/S178 | Mar 18, 2026 | 90d | Jul 28, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved (30-day notice) | P050037/S150 | Mar 18, 2026 | 29d | Jul 28, 2026 |
L LivaNova USA, Inc. |
aura6000 system | Anesthesiology | PMA | Approved | P250013 | Mar 18, 2026 | 327d | Jul 28, 2026 |
M Medtronic Neuromodulation |
InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator) | Other | PMA Supplement | Approved (30-day notice) | P970004/S446 | Mar 18, 2026 | 29d | Jul 28, 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/S024 | Mar 18, 2026 | 28d | Jul 28, 2026 |
M Medtronic Neuromodulation |
InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator) | Other | PMA Supplement | Approved (30-day notice) | P080025/S341 | Mar 18, 2026 | 29d | Jul 28, 2026 |
M Merz North America, Inc. |
RADIESSE® Injectable Implant | Surgical | PMA Supplement | Approved (30-day notice) | P050052/S175 | Mar 18, 2026 | 29d | Jul 28, 2026 |
M Merz North America, Inc. |
COAPTITE® Injectable Implant | Other | PMA Supplement | Approved (30-day notice) | P040047/S081 | Mar 18, 2026 | 29d | Jul 28, 2026 |
C CooperVision, Inc. |
Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric … | Ophthalmic | PMA Supplement | Approved (30-day notice) | P080011/S199 | Mar 18, 2026 | 20d | Jul 28, 2026 |
A A Plus Biotechnology Co., Ltd. |
APS Spear Locking Plate | Orthopedic | 510(k) | Cleared | K254053 | Mar 17, 2026 | 90d | Jul 28, 2026 |
E Elesta S.P.A |
Laser Thermal Therapy Kit | Surgical | 510(k) | Cleared | K260632 | Mar 17, 2026 | 19d | Jul 28, 2026 |
S Serim Research |
GUARDIAN Quick Dip Residual Chlorine (5212) | Other | 510(k) | Cleared | K253863 | Mar 17, 2026 | 104d | Jul 28, 2026 |
P Paragon 28, Inc. |
Grappler Suture Anchor PCFD Tether System | Orthopedic | 510(k) | Cleared | K253886 | Mar 17, 2026 | 103d | Jul 28, 2026 |
K K2m, Inc. |
Q Pedicle Instruments | Neurology | 510(k) | Cleared | K260546 | Mar 17, 2026 | 27d | Jul 28, 2026 |
S Streck, LLC |
MDx-Chex for BCY | Diagnostics | 510(k) | Cleared | K254167 | Mar 17, 2026 | 84d | Jul 28, 2026 |
T Tyto Care , Ltd. |
Tyto Insights for Eardrum Bulging Detection | Other | De Novo | Granted | DEN250014 | Mar 17, 2026 | 330d | Jul 28, 2026 |
E Encore Guards |
enCore Impression Material | Dental | 510(k) | Cleared | K251926 | Mar 17, 2026 | 267d | Jul 28, 2026 |
P Philips Medical Systems Nederland B.V. |
EchoNavigator R5.0 | Imaging | 510(k) | Cleared | K253614 | Mar 17, 2026 | 119d | Jul 28, 2026 |
C Cala Health, Inc. |
Cala kIQ Plus | Neurology | 510(k) | Cleared | K253587 | Mar 17, 2026 | 120d | Jul 28, 2026 |
C C.R. Bard, Inc. |
Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | Surgical | 510(k) | Cleared | K252971 | Mar 17, 2026 | 181d | Jul 28, 2026 |
B BTL Industries, Inc. |
Btl-785Neh | Surgical | 510(k) | Cleared | K253750 | Mar 17, 2026 | 112d | Jul 28, 2026 |
G GM Dos Reis Industria e Comercio Ltda. |
Super Upper Limbs Versalock Plating System | Orthopedic | 510(k) | Cleared | K260390 | Mar 17, 2026 | 39d | Jul 28, 2026 |
C Compal Electronics, Inc. |
BreathePal Bilevel (GFM50-MD2201) | Anesthesiology | 510(k) | Cleared | K252078 | Mar 17, 2026 | 258d | Jul 28, 2026 |
L Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. |
Electrical Scooter (SM4226) | Physical Medicine | 510(k) | Cleared | K252813 | Mar 17, 2026 | 194d | Jul 28, 2026 |
P Pulmonx Corporation |
Zephyr Endobronchial Valve (EBV) System | Anesthesiology | PMA Supplement | Approved (30-day notice) | P180002/S030 | Mar 17, 2026 | 19d | Jul 28, 2026 |
R Roche Molecular Systems, Inc. |
cobas® KRAS Mutation Test | Diagnostics | PMA Supplement | Approved (30-day notice) | P140023/S032 | Mar 17, 2026 | 18d | Jul 28, 2026 |
R Roche Molecular System, Inc. |
cobas® EZH2 Mutation Test | Diagnostics | PMA Supplement | Approved (30-day notice) | P200014/S011 | Mar 17, 2026 | 18d | Jul 28, 2026 |
R Roche Molecular Systems, Inc. |
cobas® BRAF V600 Mutation Test | Diagnostics | PMA Supplement | Approved (30-day notice) | P110020/S044 | Mar 17, 2026 | 18d | Jul 28, 2026 |
R Roche |
cobas® EGFR Mutation Test, v2.0 | Diagnostics | PMA Supplement | Approved (30-day notice) | P120019/S043 | Mar 17, 2026 | 18d | Jul 28, 2026 |
J JenaValve Technology, Inc. |
Trilogy Transcatheter Heart Valve System | Cardiovascular | PMA | Approved | P250024 | Mar 17, 2026 | 260d | Jul 28, 2026 |
R Roche Molecular Systems, Inc. |
cobas® HPV | Diagnostics | PMA Supplement | Approved (30-day notice) | P190028/S025 | Mar 17, 2026 | 18d | Jul 28, 2026 |
R Roche Molecular Systems, Inc. |
cobas® HPV | Diagnostics | PMA Supplement | Approved (30-day notice) | P100020/S065 | Mar 17, 2026 | 18d | Jul 28, 2026 |
A Abbott Medical |
Navitor Transcatheter Aortic Valve Implantation System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P190023/S031 | Mar 17, 2026 | 28d | Jul 28, 2026 |
O Orthocon, Inc. |
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Neurology | 510(k) | Cleared | K253447 | Mar 16, 2026 | 165d | Jul 28, 2026 |
S Sonio |
Sonio Detect (v3) | Imaging | 510(k) | Cleared | K252433 | Mar 16, 2026 | 227d | Jul 28, 2026 |
H Healgen Scientific,, LLC |
Healgen® Accurate Oral Fluid Drug Test | Other | 510(k) | Cleared | K253705 | Mar 16, 2026 | 112d | Jul 28, 2026 |
L Lifemotion Medical Technology Co., Ltd. |
Lifemotion Disposable Membrane Oxygenator | Cardiovascular | 510(k) | Cleared | K253838 | Mar 16, 2026 | 105d | Jul 28, 2026 |
V Voronoi Health Analytics Incorporated |
Data Analysis Facilitation Suite (DAFS) | Imaging | 510(k) | Cleared | K253944 | Mar 16, 2026 | 96d | Jul 28, 2026 |
B BAAT Medical Products B.V. |
Sinefix | Orthopedic | 510(k) | Cleared | K254176 | Mar 16, 2026 | 83d | Jul 28, 2026 |
I Izenimplant Co., Ltd. |
ZENEX Implant System_Short (R-System) | Dental | 510(k) | Cleared | K253334 | Mar 16, 2026 | 167d | Jul 28, 2026 |
S Shanghai Achieva Medical Suzhou Co., Ltd. |
DCwire Micro-guidewire | Cardiovascular | 510(k) | Cleared | K252122 | Mar 16, 2026 | 252d | Jul 28, 2026 |
S Stryker Instruments |
SurgiCount+ System | General Hospital | 510(k) | Cleared | K252282 | Mar 16, 2026 | 237d | Jul 28, 2026 |
S Shenzhen Ulike Smart Electronics Co., Ltd. |
Ulike Reglow Light Therapy Device (UM10) | Surgical | 510(k) | Cleared | K260511 | Mar 16, 2026 | 27d | Jul 28, 2026 |
P Perfuze, Ltd. |
Millipede System | Cardiovascular | 510(k) | Cleared | K253590 | Mar 16, 2026 | 119d | Jul 28, 2026 |
M Medartis AG |
APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Orthopedic | 510(k) | Cleared | K253916 | Mar 16, 2026 | 98d | Jul 28, 2026 |
M Medtronic Navigation, Inc. |
Stealth AXiS ENT clinical application | Neurology | 510(k) | Cleared | K253395 | Mar 16, 2026 | 167d | Jul 28, 2026 |
S Shenzhen Desida Technology Co., Ltd. |
LED Light Therapy Mask (Models: T2, RLD10) | Surgical | 510(k) | Cleared | K254079 | Mar 16, 2026 | 88d | Jul 28, 2026 |
C CarboFix Orthopedics , Ltd. |
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | Orthopedic | 510(k) | Cleared | K254045 | Mar 16, 2026 | 89d | Jul 28, 2026 |
O Organox Limited |
OrganOx metra® System | Other | PMA Supplement | Approved | P200035/S032 | Mar 16, 2026 | 87d | Jul 28, 2026 |
I Intera Oncology |
Medstream Programmable Infusion Pump System | General Hospital | PMA Supplement | Approved (30-day notice) | P890055/S093 | Mar 16, 2026 | 27d | Jul 28, 2026 |
I InspireMD, Ltd. |
CGuard Prime Carotid Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240029/S002 | Mar 16, 2026 | 31d | Jul 28, 2026 |
T Technomed Europe |
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) … | Physical Medicine | 510(k) | Cleared | K253581 | Mar 15, 2026 | 118d | Jul 28, 2026 |
T Taewoong Medical Co., Ltd. |
Niti-S SPAXUS Stent | Other | 510(k) | Cleared | K252648 | Mar 13, 2026 | 204d | Jul 28, 2026 |
B Beijing Infervision Healthcare Medical Technology Co., Ltd. |
InferCare RECIST | Imaging | 510(k) | Cleared | K252261 | Mar 13, 2026 | 235d | Jul 28, 2026 |
O Orthocon, Inc. |
Permatage Flowable, Settable Bone Paste | Neurology | 510(k) | Cleared | K253732 | Mar 13, 2026 | 109d | Jul 28, 2026 |
G Good Methods Global, Inc. |
Aeka Imaging | Imaging | 510(k) | Cleared | K253111 | Mar 13, 2026 | 170d | Jul 28, 2026 |
M Mars Bioimaging , Ltd. |
Extremity CT Imaging System | Imaging | 510(k) | Cleared | K252249 | Mar 13, 2026 | 238d | Jul 28, 2026 |
B Becton, Dickinson and Company |
BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Diagnostics | 510(k) | Cleared | K252040 | Mar 13, 2026 | 256d | Jul 28, 2026 |
A Aspect Imaging, Ltd. |
Embrace Neonatal MRI System | Imaging | 510(k) | Cleared | K254277 | Mar 13, 2026 | 73d | Jul 28, 2026 |
B Boston Scientific Corporation |
TheraSphere 360 Y-90 Management Platform | Imaging | 510(k) | Cleared | K260479 | Mar 13, 2026 | 28d | Jul 28, 2026 |
S Shenzhen Kingboom Technology Co., Ltd. |
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Surgical | 510(k) | Cleared | K260147 | Mar 13, 2026 | 52d | Jul 28, 2026 |
B Beckman Coulter, Inc. |
Access anti-HBc IgM | Diagnostics | 510(k) | Cleared | K254059 | Mar 13, 2026 | 86d | Jul 28, 2026 |
Z Zeto, Inc. |
New Wave System | Neurology | 510(k) | Cleared | K260455 | Mar 13, 2026 | 30d | Jul 28, 2026 |
P Pressure Products Medical Device Manufacturing, LLC |
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Cardiovascular | 510(k) | Cleared | K253799 | Mar 13, 2026 | 105d | Jul 28, 2026 |
M Medtronic Navigation, Inc. |
Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560) … | Surgical | 510(k) | Cleared | K253391 | Mar 13, 2026 | 164d | Jul 28, 2026 |
P Pegavision Corporation |
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses … | Ophthalmic | 510(k) | Cleared | K252385 | Mar 13, 2026 | 225d | Jul 28, 2026 |
C Cortex, Inc. |
OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cardiovascular | 510(k) | Cleared | K253205 | Mar 13, 2026 | 168d | Jul 28, 2026 |
C Canon Medical Systems Corporation |
Aquilion ServeSP (TSX-307B) V2.0 | Imaging | 510(k) | Cleared | K260078 | Mar 13, 2026 | 60d | Jul 28, 2026 |
G GIE Medical |
BARE Wireguided Balloon Dilation Catheter (1235) | Other | 510(k) | Cleared | K253987 | Mar 13, 2026 | 91d | Jul 28, 2026 |
S Solventum Germany GmbH |
Promogran Prisma Collagen Matrix with ORC and Silver | Other | 510(k) | Cleared | K251999 | Mar 13, 2026 | 259d | Jul 28, 2026 |
I Iasis Technologies |
IASIS i2 Relaxation Neurofeedback System | Other | 510(k) | Cleared | K252923 | Mar 13, 2026 | 179d | Jul 28, 2026 |
G Genbody.Inc. |
GenBody COVID-19 Ag Home Test | Diagnostics | 510(k) | Cleared | K251916 | Mar 13, 2026 | 263d | Jul 28, 2026 |
O Oculus Optikgeräte GmbH |
Pentacam® Cornea OCT | Ophthalmic | 510(k) | Cleared | K251848 | Mar 13, 2026 | 270d | Jul 28, 2026 |
A Abbott Medical |
Amplatzer Trevisio Intravascular Delivery System … | Cardiovascular | 510(k) | Cleared | K260499 | Mar 13, 2026 | 28d | Jul 28, 2026 |
W Weero Co., Ltd. |
Apollo Quattro (APQ-10M) | Surgical | 510(k) | Cleared | K253261 | Mar 13, 2026 | 165d | Jul 28, 2026 |
A Abbott Medical |
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Neurology | PMA Supplement | Approved (30-day notice) | P010032/S248 | Mar 13, 2026 | 28d | Jul 28, 2026 |
E Exact Sciences Corporation |
Cologuard Plus | Diagnostics | PMA Supplement | Approved (30-day notice) | P230043/S005 | Mar 13, 2026 | 35d | Jul 28, 2026 |
C Carbon Medical Technologies, Inc. |
Durasphere Injectable Bulking Agent | Other | PMA Supplement | Approved | P980053/S021 | Mar 13, 2026 | 414d | Jul 28, 2026 |
V Vantive US Healthcare, LLC |
Prismaflex TPE2000 Set | Other | PMA Supplement | Approved | P830063/S030 | Mar 13, 2026 | 91d | Jul 28, 2026 |
A Abbott Medical |
Infinity Deep Brain Stimulation (DBS) IPG | Neurology | PMA Supplement | Approved (30-day notice) | P140009/S129 | Mar 13, 2026 | 28d | Jul 28, 2026 |
A Abbott Medical |
Proclaim Doral Root Ganglion (DRG) IPG | Neurology | PMA Supplement | Approved (30-day notice) | P150004/S093 | Mar 13, 2026 | 28d | Jul 28, 2026 |
E Exact Sciences Corporation |
Cologuard® | Diagnostics | PMA Supplement | Approved (30-day notice) | P130017/S067 | Mar 13, 2026 | 35d | Jul 28, 2026 |
B Beyond Air, Inc. |
LungFit PH | Anesthesiology | PMA Supplement | Approved (30-day notice) | P200044/S013 | Mar 13, 2026 | 29d | Jul 28, 2026 |
I Inspire Medical Systems |
Model 3150 Implantable Pulse Generator (IPG) | Anesthesiology | PMA Supplement | Approved (30-day notice) | P130008/S137 | Mar 13, 2026 | 23d | Jul 28, 2026 |
S Stryker Leibinger GmbH & Co KG |
MEDPOR Customized Implant Kit | Surgical | 510(k) | Cleared | K254233 | Mar 12, 2026 | 73d | Jul 28, 2026 |
S Spectrum Medical S.R.L. |
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) … | Cardiovascular | 510(k) | Cleared | K240934 | Mar 12, 2026 | 706d | Jul 28, 2026 |
Z Zimmer, Inc. |
Affixus Retrograde Femoral Nailing System | Orthopedic | 510(k) | Cleared | K253566 | Mar 12, 2026 | 115d | Jul 28, 2026 |
S Signature Orthopaedics Pty, Ltd. |
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Orthopedic | 510(k) | Cleared | K252824 | Mar 12, 2026 | 188d | Jul 28, 2026 |
T Tyto Care , Ltd. |
Tyto Stethoscope (G3) | Cardiovascular | 510(k) | Cleared | K252089 | Mar 12, 2026 | 253d | Jul 28, 2026 |
I Implantcast GmbH |
implaFit® short stems | Orthopedic | 510(k) | Cleared | K252401 | Mar 12, 2026 | 224d | Jul 28, 2026 |
A AIRICU, Inc. |
Medical Mesh Nebulizer (AirICU Max+) | Anesthesiology | 510(k) | Cleared | K251584 | Mar 12, 2026 | 293d | Jul 28, 2026 |
G Guangzhou Ajax Medical Equipment Co., Ltd. |
Dental X-RAY Unit (AJX200) | Dental | 510(k) | Cleared | K252110 | Mar 12, 2026 | 248d | Jul 28, 2026 |
R Rapid Medical Ltd. |
Tigertriever 25 Revascularization Device | Cardiovascular | 510(k) | Cleared | K253062 | Mar 12, 2026 | 171d | Jul 28, 2026 |
A Allevion Medical, LLC |
VantageTM Lumbar Decompression Kit | Orthopedic | 510(k) | Cleared | K252546 | Mar 12, 2026 | 212d | Jul 28, 2026 |
S Spectrum Medical S.R.L. |
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Cardiovascular | 510(k) | Cleared | K252541 | Mar 12, 2026 | 212d | Jul 28, 2026 |
N Nanjing Mijo Technology Co., Ltd. |
Power Mobility Scooter (MJMA01, MJMA02) | Physical Medicine | 510(k) | Cleared | K253936 | Mar 12, 2026 | 93d | Jul 28, 2026 |
T Termosalud S.L. |
Zionic Pro Max (EMS) | Physical Medicine | 510(k) | Cleared | K253636 | Mar 12, 2026 | 113d | Jul 28, 2026 |
M Materialise NV |
Mimics Thoracic Planner | Imaging | 510(k) | Cleared | K251964 | Mar 12, 2026 | 259d | Jul 28, 2026 |
B Bionit Labs Srl |
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Neurology | 510(k) | Cleared | K260453 | Mar 12, 2026 | 29d | Jul 28, 2026 |
H HR Healthcare |
Liv Pre-lubricated Intermittent Catheter | Other | 510(k) | Cleared | K260502 | Mar 12, 2026 | 27d | Jul 28, 2026 |
F Free Flow Medical, Inc. |
LungFlow Basket Catheter | Other | 510(k) | Cleared | K254040 | Mar 12, 2026 | 86d | Jul 28, 2026 |
H Hsiner Co., Ltd. |
VPAP Pediatric Face Mask | Anesthesiology | 510(k) | Cleared | K251888 | Mar 12, 2026 | 265d | Jul 28, 2026 |
D Digestaid - Artificial Intelligence Development SA |
Deep Capsule® (Deep Capsule US) | Other | 510(k) | Cleared | K250655 | Mar 12, 2026 | 372d | Jul 28, 2026 |
T Taurus Endoscopy |
Taurus Clip | Other | 510(k) | Cleared | K253734 | Mar 12, 2026 | 108d | Jul 28, 2026 |
A A Cute Baby, Inc. |
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | Women's Health | 510(k) | Cleared | K252583 | Mar 12, 2026 | 209d | Jul 28, 2026 |
I Invera Medical |
InVera Infusion Device | Cardiovascular | 510(k) | Cleared | K250794 | Mar 12, 2026 | 363d | Jul 28, 2026 |
T Trax Surgical, Inc. |
Trax EX Anchor | Orthopedic | 510(k) | Cleared | K251750 | Mar 12, 2026 | 276d | Jul 28, 2026 |
M Medtronic Minimed, Inc. |
MiniMed Flex pump | Diagnostics | 510(k) | Cleared | K253743 | Mar 12, 2026 | 108d | Jul 28, 2026 |
P Prodeon Medical, Inc. |
Urocross Expander System (Model Numbers ES2018 and ES3025) | Other | 510(k) | Cleared | K253525 | Mar 12, 2026 | 119d | Jul 28, 2026 |
G Genadyne Biotechnologies, Inc. |
Genadyne ASTRA NPWT | Surgical | 510(k) | Cleared | K253429 | Mar 12, 2026 | 162d | Jul 28, 2026 |
E Euclid Vision Corporation |
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon … | Ophthalmic | PMA Supplement | Approved | P040029/S025 | Mar 12, 2026 | 87d | Jul 28, 2026 |
B Boston Scientific Corporation |
Ranger Paclitaxel-Coated PTA Balloon Catheter | Cardiovascular | PMA Supplement | Approved (30-day notice) | P190019/S041 | Mar 12, 2026 | 22d | Jul 28, 2026 |
N Neomend, Inc. |
PROGEL Pleural Air Leak Sealant | Anesthesiology | PMA Supplement | Approved (30-day notice) | P010047/S073 | Mar 12, 2026 | 23d | Jul 28, 2026 |
N Neomend, Inc. |
TRIDYNE Vascular Sealant | Cardiovascular | PMA Supplement | Approved (30-day notice) | P150016/S028 | Mar 12, 2026 | 23d | Jul 28, 2026 |
A Abbott Molecular, Inc. |
Alinity m HR HPV | Diagnostics | PMA Supplement | Approved | P230003/S011 | Mar 12, 2026 | 86d | Jul 28, 2026 |
I Integrum AB |
OPRA Implant System | Orthopedic | PMA Supplement | Approved | P190009/S010 | Mar 12, 2026 | 167d | Jul 28, 2026 |
Q Q-Med AB |
Restylane Injectable Gel | Surgical | PMA Supplement | Approved (30-day notice) | P040024/S148 | Mar 12, 2026 | 29d | Jul 28, 2026 |
K Kulzer, LLC |
Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Dental | 510(k) | Cleared | K260783 | Mar 11, 2026 | 1d | Jul 28, 2026 |
N Newclip Technics |
Xpert Hand | Orthopedic | 510(k) | Cleared | K253906 | Mar 11, 2026 | 96d | Jul 28, 2026 |
D Depuy Ireland UC |
INHANCE Reverse Shoulder System | Orthopedic | 510(k) | Cleared | K253624 | Mar 11, 2026 | 113d | Jul 28, 2026 |