FDA Regulatory Decisions
510(k) clearances, PMA approvals, and De Novo grants — trailing 120 days, sourced from openFDA
1701 submissions
CompanyDeviceCategoryPathwayDecisionFDA IDDecision DateReview
Medtronic, Inc.
 SynchroMed™ Infusion System; Ascenda™ Intrathecal Catheters General Hospital PMA Supplement Approved (30-day notice) P860004/S459 Aug 8, 2026 29d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P970004/S455 Aug 8, 2026 29d
Medtronic Neuromodulation
 Master Restore™; Itrel™; Synergy™; Intellis™; Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and … Neurology PMA Supplement Approved (30-day notice) P840001/S630 Aug 8, 2026 29d
Medtronic, Inc.
 Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ Neurology PMA Supplement Approved (30-day notice) P960009/S540 Aug 8, 2026 29d
Roen Surgical, Inc.
 Zamenix™ P Other 510(k) Cleared K253505 Aug 7, 2026 280d
Intuitive Surgical, Inc.
 Intuitive Endoluminal Gastrointestinal System (IG1000) Other 510(k) Cleared K253702 Aug 7, 2026 256d
Lakong Medical Devices Co., Ltd.
 Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) Dental 510(k) Cleared K251544 Aug 7, 2026 444d
Bumlicious, LLC (DBA “Bumlicious”)
 BUM Oil Women's Health 510(k) Cleared K261905 Aug 7, 2026 60d
Mediaire GmbH
 mdprostate Imaging 510(k) Cleared K252571 Aug 7, 2026 358d
The Surgical Company International B.V., doing business as TSC Life
 Mistral-Air® Warming System Cardiovascular 510(k) Cleared K261437 Aug 7, 2026 99d
Philips Medical Systems Nederland B.V.
 Zenition 30 Imaging 510(k) Cleared K254205 Aug 7, 2026 221d
Aptitude Medical Systems, Inc.
 Metrix COVID Test; Metrix COVID Test Pro Diagnostics 510(k) Cleared K253453 Aug 7, 2026 305d
Cepheid
 Xpert Hemorrhagic Fever Diagnostics 510(k) Cleared K261362 Aug 7, 2026 102d
Leica Biosystems Imaging, Inc.
 Aperio GT 450 DX; Aperio GT 180 DX Diagnostics 510(k) Cleared K253554 Aug 7, 2026 266d
Yadu Medical (Henan) Co., Ltd.
 Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) Surgical 510(k) Cleared K261028 Aug 7, 2026 130d
Leica Biosystems Imaging, Inc.
 Aperio iQC DX Software Diagnostics 510(k) Cleared K253561 Aug 7, 2026 263d
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
 Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R … General Hospital 510(k) Cleared K260933 Aug 7, 2026 140d
Shenzhen Chuangtong Yigou Technology Co., Ltd.
 LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) Surgical 510(k) Cleared K261601 Aug 7, 2026 85d
The Belport Company Inc., DBA Gingi-Pak
 PacTemp Automix NE Dental 510(k) Cleared K261937 Aug 7, 2026 58d
Arthrex, Inc.
 Arthrex Bioabsorbable PushLock Suture Anchors Orthopedic 510(k) Cleared K262357 Aug 7, 2026 28d
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
 Venue Go Imaging 510(k) Cleared K261668 Aug 7, 2026 79d
Maxx Orthopedics, Inc.
 Freedom Total Knee System (E-Poly Tibial Liners) Orthopedic 510(k) Cleared K261563 Aug 7, 2026 88d
Fujifilm Corporation
 EW10-EC02 Endoscopy Support Program Other 510(k) Cleared K260567 Aug 7, 2026 169d
Biotronik AG
 ORSIRO Sirolimus Eluting Coronary Stent System Cardiovascular PMA Supplement Approved P170030/S065 Aug 7, 2026 28d
Tiger Aesthetics Medical, LLC
 Sanae® Surgical PMA Supplement Approved P020012/S051 Aug 7, 2026 143d
Abbott Medical
 Tendyne™ Transcatheter Mitral Valve System Cardiovascular PMA Supplement Approved (30-day notice) P240042/S003 Aug 7, 2026 22d
Boston Scientific Corporation
 Axonics Sacral Neuromodulation System Other PMA Supplement Approved P180046/S113 Aug 7, 2026 56d
Guardant Health, Inc.
 Guardant360® CDx Diagnostics PMA Supplement Approved P200010/S032 Aug 7, 2026 28d
Baxter Healthcare Corporation
 PerClot® Polysaccharide Hemostatic System Surgical PMA Supplement Approved P210036/S008 Aug 7, 2026 161d
Irvine Biomedical, Inc.
 Ampere Generator Cardiovascular PMA Supplement Approved P040014/S051 Aug 7, 2026 88d
Baxter Healthcare Corporation
 PerClot® Polysaccharide Hemostatic System Surgical PMA Supplement Approved P210036/S009 Aug 7, 2026 151d
St Jude Medical
 TactiSys Quartz Equipment; Ampere Generator Cardiovascular PMA Supplement Approved P130026/S102 Aug 7, 2026 88d
St Jude Medical
 Ampere Generator Cardiovascular PMA Supplement Approved P960016/S094 Aug 7, 2026 88d
Abbott Medical
 Ampere Generator Cardiovascular PMA Supplement Approved P110016/S095 Aug 7, 2026 88d
Irvine Biomedical,Inc.(Ibi)
 Ampere Generator Cardiovascular PMA Supplement Approved P040042/S059 Aug 7, 2026 88d
Abbott Medical
 TactiSys Quartz Equipment; Ampere Generator Cardiovascular PMA Supplement Approved P220013/S033 Aug 7, 2026 88d
Boston Scientific Corporation
 Axonics Sacral Neuromodulation System Other PMA Supplement Approved P190006/S113 Aug 7, 2026 56d
Irvine Biomedical, Inc.
 Ampere Generator Cardiovascular PMA Supplement Approved P060019/S059 Aug 7, 2026 88d
Organox Limited
 OrganOx metra System Other PMA Supplement Approved (30-day notice) P200035/S041 Aug 7, 2026 22d
Nobel Biocare AB
 Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC … Dental 510(k) Cleared K253999 Aug 6, 2026 234d
Overjet, Inc.
 Overjet Multi-Image Caries and Charting Assist Imaging 510(k) Cleared K261059 Aug 6, 2026 128d
Paragon 28, Inc.
 Megalodon Dynamic Compression System Orthopedic 510(k) Cleared K261121 Aug 6, 2026 125d
Scientia Vascular, Inc.
 Aristotle Mini Guidewire Cardiovascular 510(k) Cleared K260223 Aug 6, 2026 192d
Edan Instruments, Inc.
 Telemetry Monitor (iT30, iT50) Cardiovascular 510(k) Cleared K251508 Aug 6, 2026 447d
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
 Manual Wheelchair (H008, PCK7) Physical Medicine 510(k) Cleared K261571 Aug 6, 2026 86d
Mozarc Medical Us, LLC
 Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) … Other 510(k) Cleared K253469 Aug 6, 2026 300d
Howmedica Osteonics Corp. dba Stryker Orthopaedics
 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System Orthopedic 510(k) Cleared K261898 Aug 6, 2026 62d
QIAGEN GmbH
 QIAstat-Dx BCID GPF Plus AMR Panel Diagnostics 510(k) Cleared K254194 Aug 6, 2026 226d
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/S026 Aug 6, 2026 17d
Boston Scientific Corp
 Epic™ Vascular Self-Expanding Stent System Cardiovascular PMA Supplement Approved (30-day notice) P110035/S078 Aug 6, 2026 24d
Medinol, Ltd.
 EluNIR™ Ridaforolimus Eluting Coronary Stent System Cardiovascular PMA Supplement Approved (30-day notice) P170008/S064 Aug 6, 2026 29d
Physio-Control, Inc.
 LIFEPAK® 35 monitor/defibrillator Cardiovascular PMA Supplement Approved P160026/S071 Aug 6, 2026 7d
Boston Scientific Corp
 Eluvia™ Drug-Eluting Vascular Stent System Cardiovascular PMA Supplement Approved (30-day notice) P180011/S069 Aug 6, 2026 24d
Medtronic, Inc.
 Sphere-9 Catheter AFR-00001 Cardiovascular PMA Supplement Approved (30-day notice) P240013/S030 Aug 6, 2026 22d
Boston Scientific Corporation
 Innova™ Self Expanding Stent System Cardiovascular PMA Supplement Approved (30-day notice) P140028/S087 Aug 6, 2026 24d
Farapulse, Inc.
 FARAPULSE™ Pulsed Field Ablation System Cardiovascular PMA Supplement Approved P230030/S018 Aug 6, 2026 176d
Medtronic Cryocath, LP
 Stop AF First Cardiovascular PMA Supplement Approved P100010/S152 Aug 6, 2026 359d
Xiamen Inno Medical Technology Co., Ltd.
 CAD - Lower GI (EC07-01) Other 510(k) Cleared K252853 Aug 5, 2026 331d
Tianjin Huahong Technology Co., Ltd.
 Huahong Sharps Container (HHR-I, HHR-II) General Hospital 510(k) Cleared K260845 Aug 5, 2026 142d
Class Medical , Ltd.
 Transurethral Catheter Safety Valve (TUCSV) (80050) Other 510(k) Cleared K260919 Aug 5, 2026 139d
Dental Manufacturing S.p.A.
 Ruthinium Disc Dental 510(k) Cleared K261456 Aug 5, 2026 96d
Vesalio, Inc.
 pVasc Net Mechanical Thrombectomy Device Other 510(k) Cleared K254211 Aug 5, 2026 219d
Elekta Solutions AB
 Leksell® Vantage Stereotactic System Neurology 510(k) Cleared K261932 Aug 5, 2026 57d
HCS Innovation, LLC
 NaturaJel™ Oral Wound Care Kit Other 510(k) Cleared K260120 Aug 5, 2026 202d
Convatec
 Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16) … Other 510(k) Cleared K260737 Aug 5, 2026 152d
Teleflex Medical Sdn. Bhd.
 Rusch Latex Gold Foley Catheter Other 510(k) Cleared K262056 Aug 5, 2026 48d
T.A.G. Medical Products Corporation, Ltd.
 GFS - Sterile Screws and Top Hat Orthopedic 510(k) Cleared K253858 Aug 5, 2026 245d
Proscia, Inc.
 Concentriq AP-Dx Diagnostics 510(k) Cleared K261380 Aug 5, 2026 100d
Pramand, LLC
 CraniSeal Dural Sealant Neurology PMA Supplement Approved P220014/S012 Aug 5, 2026 90d
Medtronic
 HeartWare™ HVAD™ System Cardiovascular PMA Supplement Approved P100047/S240 Aug 5, 2026 89d
Tianjin MasterVision Technology Co., Ltd.
 DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens Ophthalmic PMA Approved P220015 Aug 5, 2026 1422d
Merz North America, Inc.
 Belotero® Intense (+) Lidocaine Surgical PMA Supplement Approved (30-day notice) P250016/S001 Aug 5, 2026 26d
Medtronic Minimed, Inc.
 MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump Diagnostics PMA Supplement Approved (30-day notice) P160017/S139 Aug 5, 2026 29d
Depuy, Inc.
 ATTUNE Revision Knee System Orthopedic PMA Supplement Approved P830055/S360 Aug 5, 2026 180d
Ev3 Neurovascular
 Onyx™ Liquid Embolic System (LES) Neurology PMA Supplement Approved P030004/S042 Aug 5, 2026 138d
Edwards Lifesciences, LLC
 Edwards EVOQUE Tricuspid Valve Replacement System Cardiovascular PMA Supplement Approved (30-day notice) P230013/S032 Aug 5, 2026 30d
Medtronic Cardiac Rhythm Disease Management
 SelectSecure Lead 3830 Cardiovascular PMA Supplement Approved (30-day notice) P030036/S161 Aug 5, 2026 30d
Berlin Heart, Inc.
 EXCOR Pediatric Ventricular Assist Device Cardiovascular PMA Supplement Approved (30-day notice) P160035/S059 Aug 5, 2026 28d
Sight Sciences, Inc.
 OMNI Ultra Surgical System (1-110) General Hospital 510(k) Cleared K253760 Aug 4, 2026 252d
Duplex International Trading Limited
 LED Light Therapy Masks (PE748, PE749, PE756) Surgical 510(k) Cleared K261496 Aug 4, 2026 90d
Shenzhen Qianyu Technology Co., Ltd.
 LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4) … Surgical 510(k) Cleared K261851 Aug 4, 2026 62d
Medimetrix, LLC
 Marrow Marxman Other 510(k) Cleared K260572 Aug 4, 2026 166d
Jupiter Endovascular
 Vertex™ Thrombectomy System Cardiovascular 510(k) Cleared K261523 Aug 4, 2026 89d
Globus Medical, Inc.
 TRIVANCE™ Hip Stem Orthopedic 510(k) Cleared K254043 Aug 4, 2026 230d
3Diemme Srl
 RealGUIDE Imaging 510(k) Cleared K253902 Aug 4, 2026 242d
Philips Ultrasound, LLC
 Alturion Series Diagnostic Ultrasound System Imaging 510(k) Cleared K262311 Aug 4, 2026 27d
Medtronic, Inc.
 Sphere-9 Catheter and Affera Ablation System Cardiovascular PMA Supplement Approved (30-day notice) P240013/S029 Aug 4, 2026 25d
Boston Scientific Corporation
 Ranger™ Paclitaxel-Coated Balloon Catheter Cardiovascular PMA Supplement Approved P190019/S043 Aug 4, 2026 88d
William Cook Europe Aps
 Zenith Dissection Endovascular System (ZDEG/ZDES) Cardiovascular PMA Supplement Approved (30-day notice) P180001/S018 Aug 4, 2026 11d
Alcon Laboratories
 VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System. Ophthalmic PMA Supplement Approved P840064/S092 Aug 4, 2026 158d
Cook Medical Incorporated
 Zenith Alpha/ Alpha 2 Thoracic Endovascular Graft (ZTA/ZTA2) Cardiovascular PMA Supplement Approved (30-day notice) P140016/S018 Aug 4, 2026 11d
Cook, Inc.
 Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN) … Cardiovascular PMA Supplement Approved (30-day notice) P020018/S069 Aug 4, 2026 11d
On-X Life Technologies, Inc.
 On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (On-X AAP) Cardiovascular PMA Supplement Approved (30-day notice) P000037/S071 Aug 4, 2026 28d
Alcon Research, Ltd.
 PROVISC Ophthalmic Viscosurgical Device Ophthalmic PMA Supplement Approved P890047/S070 Aug 4, 2026 158d
Terumo Medical Corporation
 Angio Seal VIP Vascular Closure Device Cardiovascular PMA Supplement Approved P930038/S107 Aug 4, 2026 161d
ACIST Medical Systems, Inc.
 VueJect® Ultrasound Enhancing Agent Delivery System Cardiovascular 510(k) Cleared K262115 Aug 3, 2026 41d
Varian Medical Systems, Inc.
 Halcyon, Ethos Radiotherapy System (5.0) Imaging 510(k) Cleared K261856 Aug 3, 2026 60d
Paragon 28, Inc.
 Grappler Suture Anchor System Orthopedic 510(k) Cleared K262047 Aug 3, 2026 46d
Wandercraft SAS
 Eve Physical Medicine 510(k) Cleared K260381 Aug 3, 2026 179d
3-D Matrix, Inc.
 PuraStat GI Surgical 510(k) Cleared K261503 Aug 3, 2026 89d
3-D Matrix, Inc.
 PuraStat-RM Other 510(k) Cleared K261504 Aug 3, 2026 89d
Elevation Spine
 SABER-XA System Orthopedic 510(k) Cleared K261408 Aug 3, 2026 95d
Gemss Healthcare Co., LTD.
 Xlite Imaging 510(k) Cleared K260236 Aug 3, 2026 189d
Exact Sciences Corporation
 Cologuard Plus™ Diagnostics PMA Supplement Approved (30-day notice) P230043/S010 Aug 3, 2026 28d
Lynch Biologics, LLC
 GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (RABS) at Pyramid Dental PMA Supplement Approved P040013/S033 Aug 3, 2026 194d
W. L. Gore & Associates, Inc.
 GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder Cardiovascular PMA Supplement Approved P050006/S119 Aug 3, 2026 27d
Esaote, S.p.A.
 I-Genius (100019400) Imaging 510(k) Cleared K261331 Jul 31, 2026 100d
Rayence Co., Ltd.
 0909Fce, 0909Fce-Hs Imaging 510(k) Cleared K253800 Jul 31, 2026 245d
DnB Innovations, LLC
 SnØreNegatØr Dental 510(k) Cleared K261912 Jul 31, 2026 53d
Foundation Surgical Group
 Vertiwedge® Intraosseous System Orthopedic 510(k) Cleared K261810 Jul 31, 2026 60d
Hermes Medical Solutions AB
 Affinity Imaging 510(k) Cleared K253835 Jul 31, 2026 242d
ZSFab, Inc.
 ZSAlign Cervical Interbody System Orthopedic 510(k) Cleared K261451 Jul 31, 2026 91d
Itamar Medical , Ltd.
 WatchPAT SW Anesthesiology 510(k) Cleared K254042 Jul 31, 2026 227d
Foundation Surgical Group
 Interwedge® Standalone Lateral Orthopedic 510(k) Cleared K261809 Jul 31, 2026 60d
Shanghai Hulu Devices Co., Ltd.
 Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710) … Cardiovascular 510(k) Cleared K261494 Jul 31, 2026 86d
Olympus Medical Systems Corporation
 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) Other 510(k) Cleared K261183 Jul 31, 2026 112d
Siemens Healthineers AG
 MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure Imaging 510(k) Cleared K260852 Jul 31, 2026 137d
Radiaction , Ltd.
 Shield System (Siemens 30x40) Imaging 510(k) Cleared K260607 Jul 31, 2026 157d
Suzhou Haowei Medical Technology Co., Ltd.
 UniPearls® Embolic Microspheres Cardiovascular 510(k) Cleared K252812 Jul 31, 2026 330d
Intuitive Surgical, Inc.
 da Vinci Surgical System, Model IS5000 Other 510(k) Cleared K261824 Jul 31, 2026 60d
W&H Dentalwerk Bürmoos GmbH
 Angled Screwdriver MED (M-SD090) Dental 510(k) Cleared K253655 Jul 31, 2026 253d
Medtronic, Inc.
 VitalFlow Set with Balance™ Biosurface Cardiovascular 510(k) Cleared K261335 Jul 31, 2026 99d
Globus Medical, Inc.
 ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) Orthopedic 510(k) Cleared K262251 Jul 31, 2026 30d
Led Intellectual Properties, LLC
 LightStim for Wrinkles (1984); LightStim for Acne (2038) Surgical 510(k) Cleared K261482 Jul 31, 2026 87d
Neurocareai, Inc. (Dba Savelife.Ai)
 RadioViewAI Imaging 510(k) Cleared K260936 Jul 31, 2026 133d
Augmedics, Ltd.
 xvision Spine system Neurology 510(k) Cleared K261854 Jul 31, 2026 58d
3Bfab Teknoloji A.S.
 NanoCeram Resin Dental 510(k) Cleared K262681 Jul 31, 2026 1d
Samsung Electronics Co., Ltd.
 Hearing Aid Feature Other 510(k) Cleared K261187 Jul 31, 2026 112d
Tactile Medical
 Flexitouch® Plus Advanced Pneumatic Compression System Cardiovascular 510(k) Cleared K253555 Jul 31, 2026 259d
Orthalign, Inc.
 Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) Neurology 510(k) Cleared K262253 Jul 31, 2026 29d
Tusker Medical, Inc.
 Tula® System Other PMA Supplement Approved (30-day notice) P190016/S012 Jul 31, 2026 30d
Stereotaxis, Inc.
 MAGiC Ablation Catheter Cardiovascular PMA Supplement Approved P240014/S001 Jul 31, 2026 177d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ) … Cardiovascular PMA Supplement Approved (30-day notice) P010031/S929 Jul 31, 2026 24d
Medtronic Cardiac Rhythm Disease Management
 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4) … Cardiovascular PMA Supplement Approved (30-day notice) P010031/S928 Jul 31, 2026 24d
Medtronic, Inc.
 Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02) … Cardiovascular PMA Supplement Approved (30-day notice) P010015/S589 Jul 31, 2026 24d
Medtronic, Inc.
 Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa … Cardiovascular PMA Supplement Approved (30-day notice) P980035/S846 Jul 31, 2026 10d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4) … Cardiovascular PMA Supplement Approved (30-day notice) P980016/S961 Jul 31, 2026 24d
Intersect Ent.
 Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants Other PMA Supplement Approved P100044/S059 Jul 31, 2026 56d
Medtronic, Inc.
 Aurora EV ICD (DVEA3E4) Cardiovascular PMA Supplement Approved (30-day notice) P220012/S074 Jul 31, 2026 24d
Medtronic, Inc.
 Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) Cardiovascular PMA Supplement Approved (30-day notice) P150033/S229 Jul 31, 2026 24d
Medtronic, Inc.
 Aurora EV-ICD (DVEA3E4) Cardiovascular PMA Supplement Approved (30-day notice) P220012/S075 Jul 31, 2026 16d
Medtronic, Inc.
 Adapta, Versa, Sensia IPG (ADDR06, ADDRS1, ADSR01, ADSR03, ADSR06, SEDR01, SESR01) … Cardiovascular PMA Supplement Approved (30-day notice) P980035/S845 Jul 31, 2026 24d
Medtronic, Inc.
 Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01) … Cardiovascular PMA Supplement Approved (30-day notice) P010015/S588 Jul 31, 2026 24d
Medtronic Cardiac Rhythm Disease Management
 Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4) … Cardiovascular PMA Supplement Approved (30-day notice) P980016/S963 Jul 31, 2026 16d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4) … Cardiovascular PMA Supplement Approved (30-day notice) P980016/S962 Jul 31, 2026 24d
Medtronic, Inc.
 Adapta, Versa, Sensia IPG (ADDR03, ADDR06, ADSR01, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1) … Cardiovascular PMA Supplement Approved (30-day notice) P980035/S844 Jul 31, 2026 24d
OrbusNeich Medical (Shenzhen) Co., Ltd.
 Scoreflex NC Scoring PTCA Catheter Cardiovascular PMA Supplement Approved P200041/S005 Jul 31, 2026 487d
Abbott Vascular
 XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent Systems Cardiovascular PMA Supplement Approved P110019/S142 Jul 31, 2026 88d
Medtronic Cardiac Rhythm Disease Management
 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ) … Cardiovascular PMA Supplement Approved (30-day notice) P010031/S930 Jul 31, 2026 16d
Dt Medtech, LLC
 Hintermann Series H3 Total Ankle Replacement System Orthopedic PMA Supplement Approved P160036/S008 Jul 31, 2026 30d
Medtronic, Inc.
 Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) Cardiovascular PMA Supplement Approved (30-day notice) P150033/S228 Jul 31, 2026 24d
Merz North America, Inc.
 Belotero® Intense (+) Lidocaine Surgical PMA Supplement Approved (30-day notice) P250016/S002 Jul 31, 2026 16d
Medtronic, Inc.
 CareLink SmartSync Device Manager Base (24970A) Cardiovascular PMA Supplement Approved (30-day notice) P890003/S487 Jul 31, 2026 24d
Click Therapeutics, Inc.
 Motivista (CT-155) Neurology 510(k) Cleared K254038 Jul 30, 2026 226d
Salter Labs
 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) Anesthesiology 510(k) Cleared K261389 Jul 30, 2026 93d
Philips Medical Systems Nederland B.V.
 dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS … Imaging 510(k) Cleared K262330 Jul 30, 2026 21d
VertigoDx, Inc.
 SMARTVERTIGO™ Vestibular Assessment System Neurology 510(k) Cleared K260566 Jul 30, 2026 161d
T&R BIOFAB CO., Ltd.
 TnR Cranial Implant Neurology 510(k) Cleared K251959 Jul 30, 2026 399d
Misonix, LLC
 neXus Ultrasonic Surgical Aspirator System Other 510(k) Cleared K261448 Jul 30, 2026 90d
Suite 201, National Innovation Centre
 Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) Neurology 510(k) Cleared K261410 Jul 30, 2026 91d
Stryker Endoscopy
 AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down Orthopedic 510(k) Cleared K262369 Jul 30, 2026 20d
Prismatik Dentalcraft, Inc.
 Obsidian® Press Over Zirconia Dental 510(k) Cleared K262239 Jul 30, 2026 29d
Curemetrix, Inc.
 cmAngio® V2.0 Imaging 510(k) Cleared K260980 Jul 30, 2026 127d
Swift Sync, Inc.
 Sync AV II Temporary Pacing Catheter Cardiovascular 510(k) Cleared K252042 Jul 30, 2026 395d
UC-CARE , Ltd.
 SmartGuide Disposable Guides and Grids Imaging 510(k) Cleared K260161 Jul 30, 2026 191d
GE Medical Systems Ultrasound and Primary Care Diagnostics
 LOGIQ Focus Imaging 510(k) Cleared K261835 Jul 30, 2026 58d
Spirair, Inc.
 SeptAlign (SPLN001) Other 510(k) Cleared K260620 Jul 30, 2026 155d
Imgfax Co., LTD.
 Handheld Ultrasound Scanner Imaging 510(k) Cleared K261288 Jul 30, 2026 101d
Arthrex, Inc.
 Arthrex Radial Head Replacement System Orthopedic 510(k) Cleared K260624 Jul 30, 2026 154d
Boston Scientific Corporation
 AGENT™ Paclitaxel-Coated Balloon Catheter Cardiovascular PMA Supplement Approved (30-day notice) P230035/S009 Jul 30, 2026 30d
Zoll Manufacturing Corporation
 LifeVest® Wearable Defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P010030/S202 Jul 30, 2026 20d
Abbott Medical
 HeartMate 3™ Left Ventricular Assist System (LVAS) Cardiovascular PMA Supplement Approved (30-day notice) P160054/S130 Jul 30, 2026 28d
Physio-Control, Inc.
 LIFEPAK® CR2 Defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P170018/S025 Jul 30, 2026 16d
Personal Genome Diagnostics, Inc.
 PGDx elio tissue complete CDx Other PMA Approved P250036 Jul 30, 2026 323d
Nyxoah S.A.
 Genio® System 2.1 Anesthesiology PMA Supplement Approved P240024/S004 Jul 30, 2026 91d
Physio-Control, Inc.
 Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor … Cardiovascular PMA Supplement Approved (30-day notice) P160026/S070 Jul 30, 2026 14d
CenterPoint Systems, LLC
 CPS Locator 3D Plus Delivery Catheter Cardiovascular 510(k) Cleared K261766 Jul 29, 2026 62d
Cleerly, Inc.
 Cleerly Plaque Imaging 510(k) Cleared K261210 Jul 29, 2026 106d
CMT Health PTE., Ltd.
 Profoject™ Dual-Safety Pen Needles General Hospital 510(k) Cleared K261829 Jul 29, 2026 57d
Skeletal Dynamics, Inc.
 Suture Button Repair System Orthopedic 510(k) Cleared K261770 Jul 29, 2026 61d
CenterPoint Systems, LLC
 SSPC NXT Delivery Catheter Cardiovascular 510(k) Cleared K262240 Jul 29, 2026 28d
Emanate Biomedical
 Emanate Tray Other 510(k) Cleared K251908 Jul 29, 2026 404d
Cleerly, Inc.
 Cleerly LABS Imaging 510(k) Cleared K260588 Jul 29, 2026 159d
Spineart SA
 SPINEART Navigation Instrument System Neurology 510(k) Cleared K261205 Jul 29, 2026 107d
Medline Industries, LP
 NAMIC Dilator and Sheath Cardiovascular 510(k) Cleared K253526 Jul 29, 2026 258d
Sonomotion, Inc.
 Stone Clear (BWSC-LP9-02) Other 510(k) Cleared K262200 Jul 29, 2026 30d
CraniUS, LLC
 CraniUS Plate Neurology 510(k) Cleared K261058 Jul 29, 2026 120d
Edwards Lifesciences, LLC
 PASCAL Precision implant system (20000IS and 20000ISM); PASCAL Precision guide sheath system (20000GS) Cardiovascular PMA Supplement Approved (30-day notice) P220003/S031 Jul 29, 2026 29d
Edwards Lifesciences, LLC
 EDWARDS INTUITY Elite Valve, Model 8300AB Cardiovascular PMA Supplement Approved (30-day notice) P150036/S080 Jul 29, 2026 28d
Edwards Lifesciences, LLC
 Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis Model 2800 … Cardiovascular PMA Supplement Approved (30-day notice) P860057/S227 Jul 29, 2026 28d
Edwards Lifesciences, LLC
 EINSPIRIS RESILIA Aortic Valve, Model 11500A; KONECT RESILIA Aortic Valved Conduit (AVC), Model 11060A Cardiovascular PMA Supplement Approved (30-day notice) P150048/S103 Jul 29, 2026 28d
Recor Medical, Inc.
 Paradise™ Ultrasound Renal Denervation System (Paradise System); Paradise™ Catheter Cardiovascular PMA Supplement Approved (30-day notice) P220023/S012 Jul 29, 2026 29d
W. L. Gore and Associates, Inc.
 GORE® EXCLUDER® Conformable AAA Endoprosthesis Cardiovascular PMA Supplement Approved (30-day notice) P200030/S026 Jul 29, 2026 14d
Edwards Lifesciences, LLC
 Edwards SAPIEN M3 Dock (988DDS); Edwards 23F Guide Sheath (9880GS); Edwards SAPIEN M3 Crimper (9880CR) … Cardiovascular PMA Supplement Approved (30-day notice) P250019/S006 Jul 29, 2026 29d
Edwards Lifesciences, LLC
 EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK) Cardiovascular PMA Supplement Approved (30-day notice) P230013/S031 Jul 29, 2026 29d
Edwards Lifesciences, LLC
 Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26 … Cardiovascular PMA Supplement Approved (30-day notice) P140031/S208 Jul 29, 2026 29d
Edwards Lifesciences, LLC
 Edwards SAPIEN 3 Pulmonic Delivery System (9630PL29); Edwards Alterra Adaptive Prestent System (29AP4045) Cardiovascular PMA Supplement Approved (30-day notice) P200015/S081 Jul 29, 2026 29d
Contego Medical, Inc.
 Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection Cardiovascular PMA Supplement Approved (30-day notice) P240009/S012 Jul 29, 2026 29d
Caristo Diagnostics , Ltd.
 CaRi-Heart Cardiovascular De Novo Granted DEN250042 Jul 28, 2026 327d
NeuroLogica Corp., a Samsung Company
 BodyTom Elite (NL4000) Imaging 510(k) Cleared K253450 Jul 28, 2026 299d
Samsung Medison Co., Ltd.
 V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System … Imaging 510(k) Cleared K261412 Jul 28, 2026 89d
Bluewind Medical , Ltd.
 Revi System Other 510(k) Cleared K253651 Jul 28, 2026 250d
Shanghai United Imaging Healthcare Co., Ltd.
 uMI Panvivo (uMI Panvivo M) Imaging 510(k) Cleared K261427 Jul 28, 2026 89d
Nipro Medical Corporation
 Elisio™-Hx Other 510(k) Cleared K261399 Jul 28, 2026 90d
Datex-Ohmeda, Inc.
 Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) General Hospital 510(k) Cleared K260326 Jul 28, 2026 179d
Life Spine, Inc.
 TruLift Expandable System Orthopedic 510(k) Cleared K261430 Jul 28, 2026 89d
Newclip Technics
 Xpert Ankle Orthopedic 510(k) Cleared K261511 Jul 28, 2026 82d
See-Mode Technologies Pty, Ltd.
 See-Mode Augmented Reporting Tool, Breast (SMART-B) Imaging 510(k) Cleared K260303 Jul 28, 2026 179d
Hartalega NGC Sdn. Bhd.
 Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate … Surgical 510(k) Cleared K260558 Jul 28, 2026 159d
Edwards Lifesciences, LLC
 Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20; 9600TFX23; 9600TFX26; 9600TFX29) Cardiovascular PMA Supplement Approved (30-day notice) P200015/S080 Jul 28, 2026 29d
Johnson & Johnson Surgical Vision, Inc.
 Healon PRO, Healon GV PRO and Healon5 PRO Ophthalmic Viscosurgical Devices (OVD) Ophthalmic PMA Supplement Approved (30-day notice) P810031/S082 Jul 28, 2026 29d
Edwards Lifesciences, LLC
 Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29) … Cardiovascular PMA Supplement Approved (30-day notice) P140031/S207 Jul 28, 2026 29d
Corcym S.r.l.
 Carbomedics Prosthetic Heart Valve, Carbomedics® Supra-Annular Prosthetic Heart Valve … Cardiovascular PMA Supplement Approved (30-day notice) P900060/S070 Jul 28, 2026 28d
Medtronic Sofamor Danek USA, Inc.
 Infuse TM Bone Graft/Medtronic lnterbody Fusion Device Orthopedic PMA Supplement Approved P000058/S099 Jul 28, 2026 90d
Medtronic, Inc.
 Infuse™ Bone Graft Dental PMA Supplement Approved P050053/S069 Jul 28, 2026 90d
Cleveland Diagnostics, Inc.
 IsoPSA® Assay Diagnostics PMA Supplement Approved P200048/S001 Jul 28, 2026 90d
ETHICON, Inc.
 SURGICELTM POWDER Absorbable Hemostatic Powder Surgical PMA Supplement Approved N12159/S129 Jul 28, 2026 144d
Medtronic Sofamor Danek USA, Inc.
 Infuse™ Bone Graft Orthopedic PMA Supplement Approved P000054/S078 Jul 28, 2026 90d
Edwards Lifesciences, LLC
 SAPIEN M3 Transcatheter Heart Valve (9880TFX29M) Cardiovascular PMA Supplement Approved (30-day notice) P250019/S005 Jul 28, 2026 29d
Medtronic
 HeartWare® Ventricular Assist System Cardiovascular PMA Supplement Approved P100047/S239 Jul 28, 2026 84d
Xiamen High Top Electronic Technology Co., Ltd.
 Air Compression Massager (HY-1165) Physical Medicine 510(k) Cleared K260529 Jul 27, 2026 160d
Inquis Medical
 Powered Aventus Thrombectomy System™ Cardiovascular 510(k) Cleared K261105 Jul 27, 2026 115d
Philips Ultrasound, LLC
 Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System Imaging 510(k) Cleared K261211 Jul 27, 2026 104d
Merit Medical Systems, Inc.
 FlexTract Deflectable-Rotational Dilator Sheath Set Cardiovascular 510(k) Cleared K261310 Jul 27, 2026 97d
Shockwave Medical, Inc.
 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Cardiovascular 510(k) Cleared K262201 Jul 27, 2026 28d
Plus EV Holdings, Inc. D/B/A Intimate Rose
 Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange) … Physical Medicine 510(k) Cleared K250419 Jul 27, 2026 529d
Accurate Access, LLC
 ND Needle Guidance System Imaging 510(k) Cleared K262474 Jul 27, 2026 10d
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
 ARCHIMEDES Biodegradable Stent (Medium) Other 510(k) Cleared K260835 Jul 27, 2026 136d
Medtronic Ireland
 Euphora Rapid Exchange (RX) Balloon Dilatation Catheter Cardiovascular 510(k) Cleared K261759 Jul 27, 2026 60d
Siemens Healthcare Diagnostics, Inc.
 Immulite 2000 Psa Diagnostics PMA Supplement Approved (30-day notice) P930027/S039 Jul 27, 2026 28d
Biomet Microfixation, Inc.
 Total Temporomandibular Joint Replacement System Dental PMA Supplement Approved P020016/S010 Jul 27, 2026 2839d
Siemens Medical Solutions Diagnostics Limited
 IMMULITE 2000 Free PSA Diagnostics PMA Supplement Approved (30-day notice) P060005/S025 Jul 27, 2026 28d
On-X Life Technologies, Inc.
 On-X Prosthetic Heart Valves and Ascending Aortic Prothesis Cardiovascular PMA Supplement Approved (30-day notice) P000037/S070 Jul 27, 2026 27d
Siemens Healthcare Diagnostics, Inc.
 Immulite 2000 Afp Diagnostics PMA Supplement Approved (30-day notice) P010007/S026 Jul 27, 2026 28d
Teoxane S.A.
 RHA® Kiss Volume Surgical PMA Supplement Approved P170002/S055 Jul 27, 2026 90d
Analytics For Life, Inc.
 CorVista System® with PCWP Add-On Cardiovascular 510(k) Cleared K253576 Jul 26, 2026 251d
Corsano Health B.V.
 Corsano CardioWatch 287-2 System Cardiovascular 510(k) Cleared K261367 Jul 26, 2026 90d
Abbott Medical
 Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Neurology PMA Supplement Approved (30-day notice) P010032/S259 Jul 26, 2026 30d
Abbott Medical
 Dorsal Root Ganglion (DRG) IPG Neurology PMA Supplement Approved (30-day notice) P150004/S099 Jul 26, 2026 30d
Abbott Medical
 Deep Brain Stimulation (DBS) IPG Neurology PMA Supplement Approved (30-day notice) P140009/S138 Jul 26, 2026 30d
Auris Health, Inc.
 MONARCH™ Platform (MON-000008) Other 510(k) Cleared K260382 Jul 25, 2026 170d
Meticuly Co., Ltd.
 METICULY Patient-specific CMF solution Dental 510(k) Cleared K253206 Jul 25, 2026 302d
ROPCA ApS
 Diana Imaging 510(k) Cleared K260192 Jul 24, 2026 183d
Boston Scientific Corporation
 TheraSphere 360™ Y-90 Management Platform Imaging 510(k) Cleared K262462 Jul 24, 2026 7d
Nucletron B.V.
 LumenCare Azure Imaging 510(k) Cleared K262383 Jul 24, 2026 11d
Free Wheelchair Mission
 GEN 4 JOY Wheelchair Physical Medicine 510(k) Cleared K252370 Jul 24, 2026 359d
Osteoremedies, LLC
 REMEDY POLY+PLUS SNAP FIT Acetabular Cup Orthopedic 510(k) Cleared K262290 Jul 24, 2026 18d
Thermo Fisher Scientific (Oxoid Ltd.)
 Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 Diagnostics 510(k) Cleared K261781 Jul 24, 2026 56d
Rivanna Medical, Inc.
 Accuro® 3S Needle Guide Kit Imaging 510(k) Cleared K261014 Jul 24, 2026 119d
Eyekon Medical, Inc.
 Temporary Keratoprosthesis (QuickSet TKP™) Ophthalmic 510(k) Cleared K261312 Jul 24, 2026 94d
Fresenius Medical Care Renal Therapies Group, LLC
 Careflux H60;Careflux H70;Careflux V500 Other 510(k) Cleared K261267 Jul 24, 2026 99d
LIMIS Development B.V.
 PerfusiX-Imaging Other 510(k) Cleared K254180 Jul 24, 2026 213d
Cook Ireland, Ltd.
 EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes … Other 510(k) Cleared K261274 Jul 24, 2026 98d
Zavation Medical Products, LLC
 Tiger 2 System Orthopedic 510(k) Cleared K253943 Jul 24, 2026 226d
Rivanna Medical, Inc.
 Accuro 3S Imaging 510(k) Cleared K253452 Jul 24, 2026 291d
Medical Impact
 EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device … Other 510(k) Cleared K253541 Jul 24, 2026 252d
MANTIZ Co., Ltd.
 QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) Orthopedic 510(k) Cleared K260362 Jul 24, 2026 170d
Wavepulse (Xiamen) Healthcare Technology Co., Ltd.
 Air Compression Massager (EP30B001 I) Physical Medicine 510(k) Cleared K260948 Jul 24, 2026 123d
Luma Vision Limited
 VERAFEYE Imaging Catheter (VF-VIC-002) Cardiovascular 510(k) Cleared K261849 Jul 24, 2026 51d
Boston Scientific Corporation
 FARADRIVE™ Steerable Sheath (M004PF21M402) Cardiovascular 510(k) Cleared K262165 Jul 24, 2026 28d
iSMART Developments, Ltd.
 5 Wavelength LED Facemask (TN2508) Surgical 510(k) Cleared K260598 Jul 24, 2026 150d
Olympus Surgical Technologies America
 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser … Surgical 510(k) Cleared K261221 Jul 24, 2026 101d
Boston Scientific Corporation
 OBSIDIO Conformable Embolic Cardiovascular 510(k) Cleared K261488 Jul 24, 2026 79d
THINK Surgical, Inc.
 TMINI Miniature Robotic System Neurology 510(k) Cleared K261024 Jul 24, 2026 116d
Airs Medical, Inc.
 SwiftMR Imaging 510(k) Cleared K261349 Jul 24, 2026 91d
Hycor Biomedical
 NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max) … Diagnostics 510(k) Cleared K261027 Jul 24, 2026 116d
VISION MEDICAL Co., Ltd.
 Vs-370Cf, Vs-370Ct Other 510(k) Cleared K262152 Jul 24, 2026 29d
SurGenTec, LLC
 Ion-L Navigated Instruments Neurology 510(k) Cleared K262121 Jul 24, 2026 31d
Siemens Healthcare Diagnostics, Inc.
 Atellica CH Acetaminophen 2 (ACTM) Other 510(k) Cleared K261364 Jul 24, 2026 88d
Shenzhen TPH Technology Co., Ltd.
 DiscreetDuo™ Flow Wearable Breast Pump (Model S3) Women's Health 510(k) Cleared K260259 Jul 24, 2026 177d
Ge Medical Systems Information Technologies, Inc.
 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P Cardiovascular 510(k) Cleared K253277 Jul 24, 2026 298d
Deka R&D Corp
 RemunityPRO+ Pump for Remodulin® (treprostinil) Injection General Hospital 510(k) Cleared K253703 Jul 24, 2026 242d
Philips Medical Systems Nederland B.V.
 dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T … Imaging 510(k) Cleared K262294 Jul 24, 2026 17d
Defibtech, LLC
 Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300 … Cardiovascular PMA Supplement Approved P160032/S014 Jul 24, 2026 380d
Boston Scientific Corporation
 Axonics Sacral Neuromodulation System Other PMA Supplement Approved P180046/S110 Jul 24, 2026 85d
Ibsa Institut Biochimique SA
 Gelsyn-3 Orthopedic PMA Supplement Approved (30-day notice) P110005/S015 Jul 24, 2026 30d
Freenome, LLC
 SimpleScreen™ CRC Other PMA Approved P250029 Jul 24, 2026 357d
Endospan , Ltd.
 NEXUS Aortic Arch Stent Graft System Cardiovascular PMA Supplement Approved P250033/S002 Jul 24, 2026 85d
DePuy Orthopaedics, Inc.
 CERAMAX® Ceramic Total Hip System Orthopedic PMA Supplement Approved (30-day notice) P070026/S128 Jul 24, 2026 7d
Boston Scientific Corporation
 Axonics Sacral Neuromodulation System Other PMA Supplement Approved P190006/S110 Jul 24, 2026 85d
Liofilchem, Inc.
 Gepotidacin GEP 10 µg Diagnostics 510(k) Cleared K261853 Jul 23, 2026 50d
Total Joint Orthopedics, Inc.
 Klassic Infection Spacer System Orthopedic 510(k) Cleared K261734 Jul 23, 2026 58d
Beijing Konted Medical Technology Co.,Ltd
 Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) Imaging 510(k) Cleared K261081 Jul 23, 2026 113d
Candelis, Inc.
 ImageGrid StreamVue Imaging 510(k) Cleared K262143 Jul 23, 2026 28d
Shenzhen Kaiyan Medical Equipment Co., Ltd.
 FACEGYM Pro Device (HD-109) Neurology 510(k) Cleared K253932 Jul 23, 2026 226d
Microlife Corporation
 Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) Cardiovascular 510(k) Cleared K261082 Jul 23, 2026 113d
Velmeni, Inc.
 VELMENI for DENTISTS (V4D) 3D Imaging 510(k) Cleared K254096 Jul 23, 2026 216d
Total Flow Medical Limited
 Total Flow Medical Femoral Arterial (TFA) cannula Cardiovascular 510(k) Cleared K251576 Jul 23, 2026 427d
Guangzhou Daxin Health Technology Co., Ltd.
 Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) Cardiovascular 510(k) Cleared K261136 Jul 23, 2026 107d
Trividia Health, Inc.
 TRUE METRIX Self Monitoring Blood Glucose System Diagnostics 510(k) Cleared K262116 Jul 23, 2026 30d
Resvent Medical Technology Co., Ltd.
 RXiBreeze PAP System (RXiBreeze 20C) Anesthesiology 510(k) Cleared K253044 Jul 23, 2026 304d
Xvivo Perfusion AB
 Perfadex Plus Other 510(k) Cleared K261644 Jul 23, 2026 66d
Fims Co., Ltd.
 3d Cage Cervical Orthopedic 510(k) Cleared K253041 Jul 23, 2026 304d
Eko Health, Inc.
 CORE 300 Digital Stethoscope Cardiovascular 510(k) Cleared K261694 Jul 23, 2026 62d
Hefei Meyer Optoelectronic Technology, Inc.
 Dental Cone-beam Computed Tomography (mDX-15P Series) Imaging 510(k) Cleared K261748 Jul 23, 2026 56d
Esonic Technology (Wuhan) Co., Ltd.
 ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ … Imaging 510(k) Cleared K261272 Jul 23, 2026 97d
Abbott Molecular, Inc.
 Alinity m HR HPV Diagnostics PMA Supplement Approved P230003/S015 Jul 23, 2026 115d
Guidant Corp.
 Valitude™ Crt-P Is1 El (U125); Valitude™ Crt-P Is4 El (U128); Visionist™ Crt-P Is1 El (U225) … Cardiovascular PMA Supplement Approved (30-day notice) P030005/S255 Jul 23, 2026 27d
Boston Scientific Corporation
 S-Icd Emblem™ Gen 2 (A209); S-Icd Emblem™ Mri (A219) Cardiovascular PMA Supplement Approved (30-day notice) P110042/S215 Jul 23, 2026 27d
Boston Scientific
 Icd Inogen™ Vr Df4 (D010); Icd Inogen™ Vr Df1/Is1 (D011); Icd Inogen™ Dr Df4/Is1 (D012) … Cardiovascular PMA Supplement Approved (30-day notice) P960040/S516 Jul 23, 2026 27d
Biotronik AG
 Orsiro Mission larger diameter stents Ø 4.5 5.0 mm Cardiovascular PMA Supplement Approved P170030/S064 Jul 23, 2026 90d
Boston Scientific
 Essentio™ Mri Sr Sl (L110); Essentio™ Mri Dr Sl (L111); Essentio™ Mri Dr El (L131) … Cardiovascular PMA Supplement Approved (30-day notice) P150012/S189 Jul 23, 2026 27d
Johnson & Johnson Surgical Vision, Inc.
 SENSARTM 1-Piece IOL, AAB00; TECNISTM 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00 … Ophthalmic PMA Supplement Approved (30-day notice) P980040/S184 Jul 23, 2026 21d
Abbott Medical
 Current™ PFA Generator – TactiFlex Duo Cardiovascular PMA Supplement Approved P250022/S005 Jul 23, 2026 90d
Boston Scientific Corp
 Momentum™ Crt-D Is1 Df4 Is1 (G124, G125); Momentum™ Crt-D Is1 Df1 Lv1 (G126) … Cardiovascular PMA Supplement Approved (30-day notice) P010012/S613 Jul 23, 2026 27d
Abbott Medical
 TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz … Cardiovascular PMA Supplement Approved P220013/S030 Jul 23, 2026 90d
Boston Scientific Corp
 Essentio™ Sr Sl (L100); Essentio™ Dr Sl (L101); Essentio™ Dr El (L121); Proponent™ Sr Sl (L200) … Cardiovascular PMA Supplement Approved (30-day notice) N970003/S309 Jul 23, 2026 27d
Tornier, Inc.
 Tornier Perform Advanced Glenoid Orthopedic 510(k) Cleared K260721 Jul 22, 2026 139d
Sounduct
 Ossiclear (Ossiclear System) Other 510(k) Cleared K254296 Jul 22, 2026 203d
Stroke DX
 STEDI Scan Device Cardiovascular 510(k) Cleared K253840 Jul 22, 2026 233d
Merit Medical Systems, Inc.
 PreludeSYNC™ Radial Compression Device Cardiovascular 510(k) Cleared K262086 Jul 22, 2026 30d
Evolution Spine
 E3D™-C Interbody System Orthopedic 510(k) Cleared K262094 Jul 22, 2026 30d
Tianjin Huahong Technology Co., Ltd.
 Lancet Surgical 510(k) Cleared K262211 Jul 22, 2026 22d
Hamamatsu Photonics K.K.
 NanoZoomer S540MD Slide Scanner System Diagnostics 510(k) Cleared K260964 Jul 22, 2026 121d
Relja Innovations, LLC
 Lapidus Screw Kit Orthopedic 510(k) Cleared K262075 Jul 22, 2026 30d
Ecential Robotics
 Op.n™ Spine Navigation and Robotic Guidance Neurology 510(k) Cleared K261113 Jul 22, 2026 110d
Momentis Surgical , Ltd.
 Anovo Surgical System (6Ne) Surgical 510(k) Cleared K260804 Jul 22, 2026 132d
Gimmi GmbH
 AlphaTriPart - Monopolar MIC Instruments Surgical 510(k) Cleared K261179 Jul 22, 2026 103d
Advanced Bionics
 HiResolution™ Bionic Ear System Other PMA Supplement Approved P960058/S167 Jul 22, 2026 539d
Goodman Co., Ltd.
 Lacrosse NSE ALPHA Coronary Dilatation Catheter Cardiovascular PMA Supplement Approved (30-day notice) P230026/S003 Jul 22, 2026 30d
Goodman Co., Ltd.
 Lacrosse NSE ALPHA Coronary Dilatation Catheter Cardiovascular PMA Supplement Approved (30-day notice) P230026/S005 Jul 22, 2026 30d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 … Cardiovascular PMA Supplement Approved (30-day notice) P980016/S960 Jul 22, 2026 26d
Goodman Co., Ltd.
 Lacrosse NSE ALPHA Coronary Dilatation Catheter Cardiovascular PMA Supplement Approved (30-day notice) P230026/S004 Jul 22, 2026 30d
Bausch & Lomb, Inc.
 enVista® Hydrophobic Acrylic Intraocular Lens (IOL); enVista® Hydrophobic Acrylic Intraocular Lens Ophthalmic PMA Supplement Approved (30-day notice) P910056/S062 Jul 22, 2026 6d
Guardant Health, Inc.
 Shield Other PMA Supplement Approved P230009/S010 Jul 22, 2026 250d
Medtronic Cardiac Rhythm Disease Management
 Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRTD DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D1, DTBC1D4 … Cardiovascular PMA Supplement Approved (30-day notice) P010031/S927 Jul 22, 2026 26d
Bausch & Lomb, Inc.
 enVista Envy™ Hydrophobic Acrylic Intraocular Lens Ophthalmic PMA Supplement Approved (30-day notice) P240005/S006 Jul 22, 2026 6d
Rhein Laser Technologies Co., Ltd.
 Medical Thulium Fiber Laser Systems (UroFiber 150Q) Surgical 510(k) Cleared K261738 Jul 21, 2026 55d
ResolutionMD, Inc.
 ResolutionMD Imaging 510(k) Cleared K260500 Jul 21, 2026 158d
Beijing Honghugaoxiang Science and Technology Development CO
 Raney Clips Kit Neurology 510(k) Cleared K253814 Jul 21, 2026 235d
Mediclus Co., Ltd.
 One-Fil LC Dental 510(k) Cleared K261728 Jul 21, 2026 56d
Xuzhou Kernel Medical Equipment Co., Ltd.
 Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) Other 510(k) Cleared K261775 Jul 21, 2026 53d
Auris Health, Inc., part of Johnson & Johnson MedTech
 OTTAVA™ Robotic Surgical System Surgical De Novo Granted DEN250068 Jul 21, 2026 215d
O&M Halyard, Inc.
 PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves General Hospital 510(k) Cleared K262014 Jul 21, 2026 36d
Hycor Biomedical
 NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum) … Diagnostics 510(k) Cleared K260591 Jul 21, 2026 148d
GE Medical Systems SCS
 CardIQ Suite Imaging 510(k) Cleared K253770 Jul 21, 2026 237d
GM Dos Reis Industria e Comercio Ltda.
 Versalock Proximal Tibial Plating System Orthopedic 510(k) Cleared K261406 Jul 21, 2026 83d
Abbott Medical
 Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs Cardiovascular PMA Supplement Approved P910023/S482 Jul 21, 2026 203d
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
 Pipeline™ Flex Embolization Device (Pipeline™ Flex) … Neurology PMA Supplement Approved (30-day notice) P100018/S055 Jul 21, 2026 29d
Abbott Medical
 Assurity, Assurity+, Endurity, Accent family of Pacemakers Cardiovascular PMA Supplement Approved P880086/S345 Jul 21, 2026 203d
Boston Scientific Corp
 WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System … Cardiovascular PMA Supplement Approved P130013/S086 Jul 21, 2026 91d
Medtronic Minimed
 Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC Diagnostics PMA Supplement Approved (30-day notice) P150001/S111 Jul 21, 2026 29d
Medtronic Minimed, Inc.
 Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S Diagnostics PMA Supplement Approved (30-day notice) P160017/S138 Jul 21, 2026 29d
Abbott Medical
 Microny family of Pacemakers Cardiovascular PMA Supplement Approved P970013/S099 Jul 21, 2026 203d
Mentor Worldwide, LLC
 MENTOR™ MemoryShape™ Breast Implants Surgical PMA Supplement Approved P060028/S058 Jul 21, 2026 285d
Abbott Medical
 Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura … Cardiovascular PMA Supplement Approved P030054/S440 Jul 21, 2026 203d
Abbott Medical
 Assurity MRI / Endurity MRI Pacemakers Cardiovascular PMA Supplement Approved P140033/S101 Jul 21, 2026 203d
Ev3 Neurovascular
 Onyx ™ Liquid Embolic System Neurology PMA Supplement Approved (30-day notice) P030004/S044 Jul 21, 2026 26d
Medtronic Minimed, Inc.
 Simplera Sync Diagnostics PMA Supplement Approved (30-day notice) P250012/S011 Jul 21, 2026 29d
Coloplast Corp.
 Titan Inflatable Penile Prosthesis Other PMA Supplement Approved (30-day notice) P000006/S074 Jul 21, 2026 46d
Mentor Corp.
 MENTOR™ MemoryGel™ Breast Implants Surgical PMA Supplement Approved P030053/S085 Jul 21, 2026 285d
KARL STORZ Endoscopy-America, Inc.
 Photodynamic Diagnostic D-Light C System Other PMA Supplement Approved (30-day notice) P050027/S036 Jul 21, 2026 28d
Abbott Medical
 Aveir™ Leadless System Cardiovascular PMA Supplement Approved P150035/S035 Jul 21, 2026 203d
Abbott Medical
 Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps Cardiovascular PMA Supplement Approved P030035/S211 Jul 21, 2026 203d
Guardant Health, Inc.
 Shield Other PMA Supplement Approved (30-day notice) P230009/S018 Jul 21, 2026 25d
Coloplast Corp.
 Torosa Saline Filled Testicular Prosthesis Other PMA Supplement Approved (30-day notice) P020003/S012 Jul 21, 2026 46d
Medtronic Minimed
 Simplera System; Simplera Sync Diagnostics PMA Supplement Approved (30-day notice) P160007/S063 Jul 21, 2026 29d
Medtronic, Inc.
 Enlite Sensor Diagnostics PMA Supplement Approved (30-day notice) P120010/S144 Jul 21, 2026 29d
Responsive Arthroscopy, Inc.
 Thunderbolt System Orthopedic 510(k) Cleared K261632 Jul 20, 2026 63d
MacroLux Medical Technology Co., Ltd.
 BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) Other 510(k) Cleared K260516 Jul 20, 2026 153d
Aktormed GmbH
 Endoscope Holder (182214) Other 510(k) Cleared K261573 Jul 20, 2026 69d
Samsung Electronics Co., Ltd.
 Sleep Apnea Feature (v2.0) Anesthesiology 510(k) Cleared K261011 Jul 20, 2026 116d
Hi-D Imaging AG
 Hi-D Imaging 4TAVR Imaging 510(k) Cleared K261535 Jul 20, 2026 73d
Hartalega NGC Sdn. Bhd.
 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue … General Hospital 510(k) Cleared K254285 Jul 20, 2026 201d
Taiwan Surgical Corporation
 Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips Surgical 510(k) Cleared K254231 Jul 20, 2026 203d
Boston Scientific Corporation
 eCoin Peripheral Neurostimulator Other PMA Supplement Approved (30-day notice) P200036/S011 Jul 20, 2026 25d
Zimmer, Inc.
 Nexgen LPS Femoral and Tibial Knee components Orthopedic PMA Supplement Approved (30-day notice) P060037/S098 Jul 20, 2026 10d
Zimmer, Inc.
 Creep Pressure Test Update for the Nexgen LPS Bearing Knee Orthopedic PMA Supplement Approved (30-day notice) P060037/S097 Jul 20, 2026 32d
Coloplast Corp.
 Titan Inflatable Penile Prosthesis Other PMA Supplement Approved (30-day notice) P000006/S075 Jul 20, 2026 32d
Beijing Nubway S&T Co., Ltd.
 Diode laser hair removal machine (QDTM-04) Surgical 510(k) Cleared K261693 Jul 17, 2026 56d
Carl Zeiss Meditec, AG
 Zeiss Clinic 360 Imaging 510(k) Cleared K260694 Jul 17, 2026 136d
Lg Electronics.Inc
 LED LCD Monitor (OEV-271H) Other 510(k) Cleared K261614 Jul 17, 2026 63d
Natural Cycles Nordic AB
 Natural Cycles Women's Health 510(k) Cleared K253694 Jul 17, 2026 238d
Stryker Spine
 Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage … Orthopedic 510(k) Cleared K262061 Jul 17, 2026 29d
Rapid Medical Ltd.
 Drivewire 35 Guidewire Cardiovascular 510(k) Cleared K254006 Jul 17, 2026 214d
Wellspect AB
 LoFric Origo Pro Coudé Other 510(k) Cleared K261658 Jul 17, 2026 59d
Cubresa, Inc.
 Cubresa BrainPET Imaging 510(k) Cleared K253963 Jul 17, 2026 218d
Biofire Defense, LLC
 BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit Diagnostics 510(k) Cleared K261475 Jul 17, 2026 73d
Stryker Endoscopy
 SportSuite Vision Software Orthopedic De Novo Granted DEN250040 Jul 17, 2026 318d
Virasoft Corporation
 Virasight Diagnostics 510(k) Cleared K251952 Jul 17, 2026 387d
Assure Tech., LLC
 AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup Other 510(k) Cleared K261984 Jul 17, 2026 35d
Shenzhen Chuanghong Zhilian Technology Co., Ltd.
 CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) Physical Medicine 510(k) Cleared K261675 Jul 17, 2026 57d
Medtronic Sofamor Danek USA, Inc.
 Catalyft PL Expandable Interbody System Orthopedic 510(k) Cleared K253011 Jul 17, 2026 301d
Hunan Qinghao Puzhong Technology Co., Ltd.
 Dental Zirconia Blank & Coloring Liquid Dental 510(k) Cleared K261046 Jul 17, 2026 108d
Abbott Medical
 Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Neurology PMA Supplement Approved (30-day notice) P010032/S255 Jul 17, 2026 35d
Edwards Lifesciences, LLC
 Edwards Crimper: 9600CR Cardiovascular PMA Supplement Approved P140031/S192 Jul 17, 2026 345d
Edwards Lifesciences, LLC
 Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 Cardiovascular PMA Supplement Approved P200015/S069 Jul 17, 2026 345d
Abbott Medical
 Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Neurology PMA Supplement Approved (30-day notice) P140009/S134 Jul 17, 2026 35d
Roche Molecular Systems, Inc.
 cobas® BV/CV Diagnostics 510(k) Cleared K260021 Jul 16, 2026 192d
Beijing Nubway S&T Co., Ltd.
 Skin Air Cooling System (QALF-01) Surgical 510(k) Cleared K261674 Jul 16, 2026 56d
TriMed, Inc.
 TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD) … Orthopedic 510(k) Cleared K262032 Jul 16, 2026 29d
Pioneer Surgical Technology, Inc.
 Cable-Ready® Cable Grip System Orthopedic 510(k) Cleared K261271 Jul 16, 2026 90d
Bethesda Medical Devices, LLC
 Palisades™ Buttress Plate System Orthopedic 510(k) Cleared K261309 Jul 16, 2026 86d
Scientia Vascular, Inc.
 Socrates Aspiration System (Socrates 70 Aspiration Catheter) Cardiovascular 510(k) Cleared K260002 Jul 16, 2026 195d
Karl Storz Se & Co. Kg
 Endomat Select (UP220) Women's Health 510(k) Cleared K261706 Jul 16, 2026 55d
Medtronic, Inc.
 Aurora EV ICD Cardiovascular PMA Supplement Approved (30-day notice) P220012/S073 Jul 16, 2026 30d
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/S587 Jul 16, 2026 30d
Abbott Medical
 HeartMate 3™ Left Ventricular Assist System (LVAS) Cardiovascular PMA Supplement Approved (30-day notice) P160054/S129 Jul 16, 2026 28d
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/S843 Jul 16, 2026 30d
ZOLL Medical Corporation
 AED 3; CPR Uni-Padz Cardiovascular PMA Supplement Approved P160015/S028 Jul 16, 2026 45d
Terumo Medical Corporation
 MISAGO(TM) RX Self-expanding Peripheral Stent Cardiovascular PMA Supplement Approved P140002/S032 Jul 16, 2026 199d
Medtronic Cardiac Rhythm Disease Management
 Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD … Cardiovascular PMA Supplement Approved (30-day notice) P980016/S959 Jul 16, 2026 30d
Medtronic, Inc.
 Symplicity Spyral™ Renal Denervation System Cardiovascular PMA Supplement Approved P220026/S017 Jul 16, 2026 87d
Kestra Medical Technologies, Inc.
 ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) Cardiovascular PMA Supplement Approved (30-day notice) P200037/S020 Jul 16, 2026 23d
Medtronic Cardiac Rhythm Disease Management
 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D … Cardiovascular PMA Supplement Approved (30-day notice) P010031/S926 Jul 16, 2026 30d
Boston Scientific Corp
 Vercise Deep Brain Stimulation (DBS) Systems Neurology PMA Supplement Approved (30-day notice) P150031/S096 Jul 16, 2026 30d
Inquis Medical
 Aventus Thrombectomy System Cardiovascular 510(k) Cleared K262030 Jul 15, 2026 28d
CMT Health PTE., Ltd.
 Profoject™ Pen Needles (Model A; Model B) General Hospital 510(k) Cleared K260739 Jul 15, 2026 131d
Huneo, LLC
 WRAP System Anesthesiology 510(k) Cleared K260050 Jul 15, 2026 189d
Kyocera Medical Technologies, Inc.
 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System Orthopedic 510(k) Cleared K261353 Jul 15, 2026 82d
Hamamatsu Photonics K.K.
 NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system Diagnostics 510(k) Cleared K253606 Jul 15, 2026 239d
Atlas Spine, Inc.
 Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant Orthopedic 510(k) Cleared K252822 Jul 15, 2026 314d
ThinkSono GmbH
 ThinkSono Guidance Imaging 510(k) Cleared K260338 Jul 15, 2026 163d
Dongguan Miqiang Technology Co., Ltd.
 XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451 … Surgical 510(k) Cleared K261407 Jul 15, 2026 77d
UPlanner B.V. - Presurgeo
 SkeletonPlanner Imaging 510(k) Cleared K260206 Jul 15, 2026 173d
Abbott Medical
 EnSite™ X EP System Cardiovascular 510(k) Cleared K262006 Jul 15, 2026 30d
Better Diagnostics AI Corp.
 Better Diagnostics Dental Assist (BDDA) Version 1.0 Imaging 510(k) Cleared K260851 Jul 15, 2026 121d
Stryker Leibinger GmbH & Co KG
 Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant Neurology PMA Supplement Approved P130014/S022 Jul 15, 2026 209d
Davol Inc., Sub. C. R. Bard, Inc.
 Avitene Microfibrillar Collagen Hemostat (MCH) Flour … Surgical PMA Supplement Approved (30-day notice) N17600/S047 Jul 15, 2026 23d
Davol, Inc.
 Arista™ AH Surgical PMA Supplement Approved (30-day notice) P050038/S044 Jul 15, 2026 23d
Vantive US Healthcare, LLC
 Prismaflex Tpe2000 Set Other PMA Supplement Approved (30-day notice) P830063/S032 Jul 15, 2026 29d
Cryolife, Inc.
 BioGlue® Surgical Adhesive Cardiovascular PMA Supplement Approved P010003/S043 Jul 15, 2026 91d
Depuy, Inc.
 LCS® Total Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S368 Jul 15, 2026 7d
Traferox Technologies, Inc.
 TorEx Lung Perfusion System Other PMA Approved P250025 Jul 15, 2026 373d
C.R. Bard, Inc.
 Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web Surgical PMA Supplement Approved (30-day notice) P800002/S035 Jul 15, 2026 23d
Medtronic Sofamor Danek USA, Inc.
 Symmetrix™ L Spinal System Orthopedic 510(k) Cleared K261020 Jul 14, 2026 109d
Luwi, LLC
 Lixi (Lxosfm1) Women's Health 510(k) Cleared K253662 Jul 14, 2026 236d
Alphatec Spine, Inc.
 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System Orthopedic 510(k) Cleared K261284 Jul 14, 2026 88d
Jochu Technology Co., Ltd.
 IERO Mobility Scooter (IERO-01) Physical Medicine 510(k) Cleared K261232 Jul 14, 2026 90d
Intuitive Surgical, Inc.
 Universal Seal (5-12 mm) Other 510(k) Cleared K261249 Jul 14, 2026 89d
Affirm Medical Technologies II, LLC
 VisuBreath Anesthesiology 510(k) Cleared K261633 Jul 14, 2026 57d
Ambu A/S
 Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US … Neurology 510(k) Cleared K260578 Jul 14, 2026 144d
Sp Medical A/S
 Accoat Guide Wire Cardiovascular 510(k) Cleared K253667 Jul 14, 2026 235d
Flow Neuroscience AB
 Flow FL-100 Neurology PMA Supplement Approved P230024/S001 Jul 14, 2026 90d
Abbott Vascular, Inc.
 Perclose ProStyle Suture-Mediated Closure and Repair System Cardiovascular PMA Supplement Approved (30-day notice) P960043/S136 Jul 14, 2026 28d
ZOLL Medical Corporation
 OneStep CPR Complete Electrodes, OneStep CPR Complete Adult/Child Electrodes, OneStep CPR AA Electrodes … Cardiovascular PMA Supplement Approved (30-day notice) P160022/S053 Jul 14, 2026 12d
Medtronic, Inc.
 Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System … Cardiovascular PMA Supplement Approved P130021/S185 Jul 14, 2026 90d
Acu Focus, Inc.
 IC-8 Apthera Intraocular Lens (IOL) Ophthalmic PMA Supplement Approved P210005/S010 Jul 14, 2026 431d
Guardant Health, Inc.
 Guardant360 CDx Diagnostics PMA Supplement Approved (30-day notice) P200010/S030 Jul 14, 2026 28d
Meta Platform Technologies, LLC
 Hearing assist Other 510(k) Cleared K254044 Jul 13, 2026 208d
iSchemaview
 Rapid Vessel Occlusion (Rapid VO) Imaging 510(k) Cleared K261085 Jul 13, 2026 103d
embecta Medical II, LLC
 Ultra-Fine™ SAFETY Insulin Syringe General Hospital 510(k) Cleared K260208 Jul 13, 2026 171d
Shenzhen TPH Technology Co., Ltd.
 Wearable Breast Pump (Model S32A) Women's Health 510(k) Cleared K261199 Jul 13, 2026 91d
Classys, Inc.
 Volnewmer™ Surgical 510(k) Cleared K253504 Jul 13, 2026 255d
Merit Medical Ireland , Ltd.
 Merit MAK Nitinol/Gold-Tungsten Guide Wire Cardiovascular 510(k) Cleared K261640 Jul 13, 2026 56d
Balt USA, LLC
 SLIM Microcatheter Cardiovascular 510(k) Cleared K260199 Jul 13, 2026 172d
W. L. Gore & Associates, Inc.
 GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Cardiovascular PMA Supplement Approved P210032/S026 Jul 13, 2026 31d
Microcube, LLC
 Minitouch 3.8 Era System (Minitouch System) Women's Health PMA Supplement Approved P230002/S002 Jul 13, 2026 220d
Biomet Manufacturing Corp
 Oxford™ Partial Knee System Orthopedic PMA Supplement Approved (30-day notice) P010014/S117 Jul 13, 2026 28d
Medtronic Neuromodulation
 Altaviva™ Other PMA Supplement Approved P240011/S010 Jul 13, 2026 144d
Avara Software
 Avara Viewer Imaging 510(k) Cleared K262120 Jul 10, 2026 17d
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert … Orthopedic 510(k) Cleared K261624 Jul 10, 2026 56d
ACON Laboratories, Inc.
 Flowflex Plus RSV + Flu A/B + COVID Rapid Test Diagnostics 510(k) Cleared K261212 Jul 10, 2026 87d
Philips Medical Systems B.V.
 SmartCT (R3.0 (L10)) Imaging 510(k) Cleared K253670 Jul 10, 2026 231d
Cochlear Americas
 Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger … Other 510(k) Cleared K260902 Jul 10, 2026 114d
MedSource Labs, LLC
 ClearSafe Closed System General Hospital 510(k) Cleared K261041 Jul 10, 2026 101d
New York Embroidery Studio
 NYES Tuff Cuff L3 Disposable Gowns Surgical 510(k) Cleared K261949 Jul 10, 2026 29d
Masimo Corporation
 SedLine Sedation Monitor Neurology 510(k) Cleared K260880 Jul 10, 2026 115d
Free Flow Medical, Inc.
 LungFlow Airway Catheter Other 510(k) Cleared K254037 Jul 10, 2026 206d
Varian Medical Systems
 AI Contouring (VA10A) Imaging 510(k) Cleared K261306 Jul 10, 2026 81d
Signus Medinzintechnik GmbH
 Poseidon St Orthopedic 510(k) Cleared K261031 Jul 10, 2026 102d
Boston Scientific Corporation
 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System Surgical 510(k) Cleared K261978 Jul 10, 2026 28d
C.R. Bard, Inc.
 Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) … Other 510(k) Cleared K253514 Jul 10, 2026 246d
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
 Sofia Lyme FIA; Sofia 2 Campylobacter FIA Diagnostics 510(k) Cleared K254295 Jul 10, 2026 191d
Capenergy Medical S.L.
 Capenergy C Equipments RF C200 and C400 Drakarian Surgical 510(k) Cleared K253480 Jul 10, 2026 269d
Zhejiang Lumbre Electric Appliance Co., Ltd.
 Electric Wheelchair (DY611A-2, DY612A-1) Physical Medicine 510(k) Cleared K261149 Jul 10, 2026 93d
Abbott Medical
 Volt™ PFA System Cardiovascular PMA Supplement Approved P250022/S006 Jul 10, 2026 60d
Farapulse, Inc.
 FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) Cardiovascular PMA Supplement Approved (30-day notice) P230030/S022 Jul 10, 2026 30d
Boston Scientific Corp
 Precision Spinal Cord Stimulator (SCS) Systems Neurology PMA Supplement Approved (30-day notice) P030017/S397 Jul 10, 2026 28d
Boston Scientific Corp
 Vercise Deep Brain Stimulation (DBS) Systems Neurology PMA Supplement Approved (30-day notice) P150031/S095 Jul 10, 2026 28d
Medtronic, Inc.
 HexaGen RF Generator Software and Remote Cardiovascular PMA Supplement Approved P240013/S026 Jul 10, 2026 88d
Inspire Medical Systems
 Model 3150 Implantable Pulse Generator (IPG) Anesthesiology PMA Supplement Approved P130008/S140 Jul 10, 2026 71d
Medtronic Vascular, Inc.
 Protege™ GPS™ Self-expanding Peripheral Stent System Cardiovascular PMA Supplement Approved (30-day notice) P060001/S058 Jul 10, 2026 14d
Medtronic Vascular, Inc.
 EverFlex™ Self-expanding Peripheral Stent System Cardiovascular PMA Supplement Approved (30-day notice) P110023/S068 Jul 10, 2026 14d
Procept Biorobotics
 HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) Surgical 510(k) Cleared K260723 Jul 9, 2026 126d
Teleflex Medical, LLC
 Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture Surgical 510(k) Cleared K261988 Jul 9, 2026 27d
Zeta Surgical, Inc.
 Zeta TMS Navigation System Neurology 510(k) Cleared K261471 Jul 9, 2026 66d
Perfuze, Ltd.
 Millipede88 Access Catheter Cardiovascular 510(k) Cleared K253901 Jul 9, 2026 216d
Smith & Nephew, Inc.
 Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) … Orthopedic 510(k) Cleared K261968 Jul 9, 2026 28d
MedSource Labs, LLC
 MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter General Hospital 510(k) Cleared K260539 Jul 9, 2026 142d
Pinkslip, LLC
 PINKSLIP Water-Based Personal Lubricant and Moisturizer Women's Health 510(k) Cleared K261177 Jul 9, 2026 90d
Lifesignals, Inc.
 UbiqVue™ 2AYe Cardiac System (UX2253) Cardiovascular 510(k) Cleared K261569 Jul 9, 2026 58d
Medtronic MiniMed
 SmartGuard Technology; Predictive Low Glucose Technology Diagnostics 510(k) Cleared K261962 Jul 9, 2026 28d
Synergen Technology Labs, LLC
 ScioCardio ECG Analysis Platform Cardiovascular 510(k) Cleared K252978 Jul 9, 2026 295d
Provect.AI
 3D-Anywhere Imaging 510(k) Cleared K253899 Jul 9, 2026 216d
DiaDent Group International
 Dia-Cem Dental 510(k) Cleared K261166 Jul 9, 2026 91d
LifeLens Technologies, Inc.
 LifeLens Physiological Monitor Cardiovascular 510(k) Cleared K260157 Jul 9, 2026 170d
Lutonix
 Lutonix™ 018 Drug Coated Balloon PTA Catheter Cardiovascular PMA Supplement Approved P170003/S029 Jul 9, 2026 91d
Abbott Medical
 HeartMate 3™ Left Ventricular Assist System Cardiovascular PMA Supplement Approved (30-day notice) P160054/S128 Jul 9, 2026 27d
Abbott Medical
 Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T) … Cardiovascular PMA Supplement Approved (30-day notice) P910023/S486 Jul 9, 2026 29d
Lutonix
 Lutonix™ 035 Drug Coated Balloon Catheter Cardiovascular PMA Supplement Approved P130024/S045 Jul 9, 2026 91d
Abbott Medical
 Navitor Transcatheter Aortic Valve Implantation System Cardiovascular PMA Supplement Approved P190023/S034 Jul 9, 2026 27d
Syncardia Systems, LLC
 SynCardia Temporary Total Artificial Heart (TAH-t) System – Freedom Driver System Cardiovascular PMA Supplement Approved (30-day notice) P030011/S099 Jul 9, 2026 27d
Merz North America, Inc.
 Belotero® Intense (+) Lidocaine Surgical PMA Approved P250016 Jul 9, 2026 387d
Abbott Medical
 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Cardiovascular PMA Supplement Approved P230036/S017 Jul 9, 2026 99d
Medtronic, Inc.
 Avalus Bioprosthesis Cardiovascular PMA Supplement Approved (30-day notice) P170006/S045 Jul 9, 2026 28d
Abbott Medical
 HeartMate II Left Ventricular Assist System Cardiovascular PMA Supplement Approved (30-day notice) P060040/S125 Jul 9, 2026 27d
Renata Medical, Inc.
 Minima Pro Stent System Cardiovascular PMA Supplement Approved P240003/S006 Jul 9, 2026 198d
Abbott Medical
 Avant (CDHFA700Q, CDHFA700T, CDHFA700D); Neutrino NxT (CDHFA800Q, CDHFA800T, CDHFA800B, CDHFA800D, CDHFA600Q … Cardiovascular PMA Supplement Approved (30-day notice) P030054/S445 Jul 9, 2026 29d
Sirtex Medical, Inc.
 Lava Liquid Embolic System (Lava LES) Cardiovascular PMA Supplement Approved (30-day notice) P220020/S008 Jul 9, 2026 27d
JenaValve Technology, Inc.
 Trilogy Transcatheter Heart Valve System Cardiovascular PMA Supplement Approved (30-day notice) P250024/S003 Jul 9, 2026 17d
Neurocareai, Inc. (Dba Savelife.Ai)
 CXRDetectAI Imaging 510(k) Cleared K253751 Jul 8, 2026 225d
Newclip Technics
 Alians Elbow S Orthopedic 510(k) Cleared K261191 Jul 8, 2026 86d
BlueDop Medical, Ltd.
 BlueDop Vascular Expert Cardiovascular 510(k) Cleared K260700 Jul 8, 2026 126d
Roche Molecular Systems, Inc.
 cobas CT/NG for use on the cobas 5800/6800/8800 systems … Diagnostics 510(k) Cleared K260917 Jul 8, 2026 111d
Formlabs Ohio, Inc.
 Denture Base Resin V2 Dental 510(k) Cleared K262300 Jul 8, 2026 1d
Stihler Electronic GmbH
 ThermAffyx(TM) Patient Safety System Cardiovascular 510(k) Cleared K260278 Jul 8, 2026 160d
C.A. Medical, LLC
 C.A. Medical Interbody Fusion System Orthopedic 510(k) Cleared K254130 Jul 8, 2026 198d
Ningbo Resshidi Medical Devices Co., Ltd.
 Electric Wheelchair Physical Medicine 510(k) Cleared K261396 Jul 8, 2026 70d
Varian Medical Systems, Inc.
 Virtual Cone (1.0) Imaging 510(k) Cleared K260750 Jul 8, 2026 124d
bioMerieux, Inc.
 VITEK REVEAL GN AST Assay and VITEK REVEAL AST System Diagnostics 510(k) Cleared K260160 Jul 8, 2026 169d
Alcon Laboratories, Inc.
 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems Ophthalmic PMA Supplement Approved (30-day notice) P930014/S164 Jul 8, 2026 28d
Channel Medsystems, Inc.
 Cerene® Cryotherapy Device Women's Health PMA Supplement Approved P180032/S023 Jul 8, 2026 26d
W. L. Gore and Associates, Inc.
 GORE® EXCLUDER® Conformable AAA Endoprosthesis Cardiovascular PMA Supplement Approved P200030/S025 Jul 8, 2026 76d
W. L. Gore & Associates, Inc.
 GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis Cardiovascular PMA Supplement Approved P020004/S207 Jul 8, 2026 76d
Organox Limited
 OrganOx metra System Other PMA Supplement Approved (30-day notice) P200035/S040 Jul 8, 2026 30d
Coloplast A.S.
 Luja Soft Other 510(k) Cleared K262045 Jul 7, 2026 20d
Yongkang Ruihe Metal Product Co., Ltd.
 Electric wheelchair (XW-LY007 ) Physical Medicine 510(k) Cleared K261164 Jul 7, 2026 89d
HOYA Lamphun , Ltd.
 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens … Ophthalmic 510(k) Cleared K261812 Jul 7, 2026 36d
Mirion Technologies (Capintec), Inc.
 Pulmonex II Xenon System (132-503) Imaging 510(k) Cleared K253942 Jul 7, 2026 210d
Beijing Infervision Healthcare Medical Technology Co., Ltd.
 InferOperate Suite Imaging 510(k) Cleared K260973 Jul 7, 2026 105d
Yongkang Ruihe Metal Product Co., Ltd.
 Mobility Scooter (R200) Physical Medicine 510(k) Cleared K261163 Jul 7, 2026 89d
Organox Limited
 OrganOx metra® System Other PMA Supplement Approved P200035/S037 Jul 7, 2026 89d
CooperVision, Inc.
 comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear Ophthalmic PMA Supplement Approved (30-day notice) P080011/S203 Jul 7, 2026 22d
Boston Scientific Corporation
 EMBLEM™ S-ICD Electrode (Lead) Model 3501 Cardiovascular PMA Supplement Approved P110042/S210 Jul 7, 2026 113d
MicroVention, Inc.
 Roadsaver/CASPER Carotid Stent System Cardiovascular PMA Supplement Approved (30-day notice) P210030/S002 Jul 7, 2026 28d
GC America, Inc.
 Cytrans™ Elashield Dental 510(k) Cleared K253317 Jul 6, 2026 279d
Smith & Nephew, Inc.
 TESSA Spatial Surgery System; INTELLIO Tablet (72205455) Orthopedic De Novo Granted DEN250037 Jul 6, 2026 318d
SteriLance Medical (Suzhou), Inc.
 Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) Surgical 510(k) Cleared K260122 Jul 6, 2026 172d
PCCA, Inc.
 Plum Vagiceuticals™ Vaginal Moisturizing Suppositories Women's Health 510(k) Cleared K261909 Jul 6, 2026 28d
Waldemar Link GmbH & Co. KG
 MobileLink Acetabular Cup System – 40mm ID Inserts (various) Orthopedic 510(k) Cleared K261009 Jul 6, 2026 102d
Indigo Technologies
 Indira Cloud Viewer Imaging 510(k) Cleared K261465 Jul 6, 2026 63d
Hartman Medical Group, LLC
 Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / … Cardiovascular 510(k) Cleared K261529 Jul 6, 2026 59d
Alcon Laboratories, Inc.
 Acrosof Posterior Chamber Intraocular Lens Ophthalmic PMA Supplement Approved (30-day notice) P930014/S163 Jul 6, 2026 27d
Guardant Health, Inc.
 Guardant360 CDx Diagnostics PMA Supplement Approved (30-day notice) P200010/S031 Jul 6, 2026 20d
Medtronic, Inc.
 Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ Neurology PMA Supplement Approved (30-day notice) P960009/S538 Jul 6, 2026 25d
Alcon Laboratories, LLC
 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) … Ophthalmic PMA Supplement Approved (30-day notice) P190018/S053 Jul 6, 2026 27d
Guardant Health, Inc.
 Guardant360® Liquid CDx Diagnostics PMA Supplement Approved (30-day notice) P250027/S001 Jul 6, 2026 20d
NuMED, Inc.
 CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426) … Cardiovascular PMA Supplement Approved P150028/S007 Jul 6, 2026 350d
Alcon Research, Ltd.
 AcrySof ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL Ophthalmic PMA Supplement Approved (30-day notice) P040020/S120 Jul 6, 2026 27d
Synergy Spine Solutions, Inc.
 Synergy Disc Orthopedic PMA Supplement Approved (30-day notice) P250028/S002 Jul 6, 2026 25d
Align Technology , Ltd.
 iTero Lumina™ Pro Dental 510(k) Cleared K261847 Jul 2, 2026 29d
Koios Medical, Inc.
 Koios DS (3.8) Imaging 510(k) Cleared K253884 Jul 2, 2026 210d
Abbott
 Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter Cardiovascular 510(k) Cleared K261825 Jul 2, 2026 30d
Fujifilm Corporation
 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 Other 510(k) Cleared K261880 Jul 2, 2026 27d
Oncosoft. Inc.
 OncoStudio Imaging 510(k) Cleared K260528 Jul 2, 2026 135d
Claria Medical, Inc.
 Claria System Women's Health De Novo Granted DEN250034 Jul 2, 2026 329d
BPEndo, LLC
 Insufflation Retention Device (IRD) (11173-325-101) Other 510(k) Cleared K261587 Jul 2, 2026 50d
Ventris Medical
 Collagen Wound Powder Other 510(k) Cleared K260596 Jul 2, 2026 128d
Avinent Implant System S.L.U.
 FACE4D Aligner Dental 510(k) Cleared K260527 Jul 2, 2026 135d
Implicity, Inc.
 ILR ECG Analyzer (IM007) Cardiovascular 510(k) Cleared K253463 Jul 2, 2026 267d
Cepheid®
 Xpert Carba-R Diagnostics 510(k) Cleared K261867 Jul 2, 2026 28d
Spident Co., Ltd.
 OrthoFit Dental 510(k) Cleared K261129 Jul 2, 2026 87d
O&M Halyard, Inc.
 HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology … General Hospital 510(k) Cleared K261897 Jul 2, 2026 27d
iHealthscreen, Inc.
 iPredict-DR Ophthalmic 510(k) Cleared K253704 Jul 2, 2026 220d
Edan Instruments, Inc.
 SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) Cardiovascular 510(k) Cleared K252463 Jul 2, 2026 330d
Suzhou Precigenome, Ltd. Co
 Fastplex™ BCR-ABL (p210) %IS digital PCR Kit Other 510(k) Cleared K252243 Jul 2, 2026 349d
Optrascan, Inc.
 OptraSCAN System Diagnostics 510(k) Cleared K260755 Jul 2, 2026 115d
Abbott Medical
 Etema™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Neurology PMA Supplement Approved (30-day notice) P010032/S253 Jul 2, 2026 27d
Caris Life Sciences
 MI Cancer Seek Other PMA Supplement Approved (30-day notice) P240010/S010 Jul 2, 2026 29d
Alcon Research, Ltd.
 AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL Ophthalmic PMA Supplement Approved (30-day notice) P040020/S119 Jul 2, 2026 24d
Edwards Lifesciences, LLC
 Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve … Cardiovascular PMA Supplement Approved (30-day notice) P140031/S206 Jul 2, 2026 7d
Edwards Lifesciences, LLC
 Edwards SAPIEN 3 Transcatheter Heart Valve Cardiovascular PMA Supplement Approved (30-day notice) P200015/S079 Jul 2, 2026 7d
Alcon Research, Ltd.
 AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses Ophthalmic PMA Supplement Approved (30-day notice) P040020/S121 Jul 2, 2026 22d
Alcon Laboratories, LLC
 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) … Ophthalmic PMA Supplement Approved (30-day notice) P190018/S052 Jul 2, 2026 24d
Abbott Medical
 Liberta RC™ Deep Brain Stimulation (DBS) IPG Neurology PMA Supplement Approved (30-day notice) P140009/S132 Jul 2, 2026 27d
Teoxane S.A.
 RHA® Redensity, RHA® Redensity Mepi Surgical PMA Supplement Approved P170002/S052 Jul 2, 2026 177d
Alcon Laboratories, Inc.
 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems Ophthalmic PMA Supplement Approved (30-day notice) P930014/S165 Jul 2, 2026 22d
Alcon Laboratories, LLC
 Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) … Ophthalmic PMA Supplement Approved (30-day notice) P190018/S054 Jul 2, 2026 22d
Biomet, Inc.
 OSSTM Orthopedic Salvage System Orthopedic 510(k) Cleared K253434 Jul 1, 2026 273d
Ivoclar Vivadent, Inc.
 Tetric plus Fill;Tetric plus Flow Dental 510(k) Cleared K261485 Jul 1, 2026 57d
S.M.A.I.O
 KHEIRON® Spinal Fixation System, including patient specific K-ROD Orthopedic 510(k) Cleared K253802 Jul 1, 2026 215d
Termosalud S.L.
 Chromix Surgical 510(k) Cleared K261473 Jul 1, 2026 58d
Olympus Medical Systems Corp.
 THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) … Surgical 510(k) Cleared K254056 Jul 1, 2026 196d
Chirana T.Injecta,A.S.
 Enteral Syringe (20ml, 60ml) Other 510(k) Cleared K252483 Jul 1, 2026 328d
SeaSpine Orthopedics Corporation
 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System … Orthopedic 510(k) Cleared K253420 Jul 1, 2026 273d
Dentca, Inc.
 DENTCA Tru Flexible Dental 510(k) Cleared K261474 Jul 1, 2026 58d
Winter Innovations, Inc.
 EasyWhip Family Surgical 510(k) Cleared K261021 Jul 1, 2026 96d
Restor3D
 Veritas Shoulder System Orthopedic 510(k) Cleared K260556 Jul 1, 2026 132d
Ortoma AB
 OTS Hip Neurology 510(k) Cleared K261852 Jul 1, 2026 28d
Ultradent Products, Inc.
 Transcend Bulk Fill Flowable Composite Dental 510(k) Cleared K262228 Jul 1, 2026 1d
Stryker Leibinger GmbH & Co KG
 RibPlate System Orthopedic 510(k) Cleared K261054 Jul 1, 2026 92d
Covidien, LLC
 Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) … General Hospital 510(k) Cleared K253527 Jul 1, 2026 230d
JJGC Indústria e Comércio de Materiais Dentários S.A.
 Neodent Implant System - NeoConvert Fit Dental 510(k) Cleared K261147 Jul 1, 2026 85d
Stryker Neurovascular
 Trevo Trak 21 Microcatheter Cardiovascular 510(k) Cleared K261889 Jul 1, 2026 26d
Novocure, GmbH
 Optune Pax® Surgical PMA Supplement Approved P250034/S001 Jul 1, 2026 68d
Boston Scientific
 LATITUDE™ NXT Remote Patient Management System; LATITUDE™ NXT System Server Software Model 6460 Cardiovascular PMA Supplement Approved P910077/S198 Jul 1, 2026 89d
Novocure, GmbH
 Optune Lua® Anesthesiology PMA Supplement Approved P230042/S008 Jul 1, 2026 68d
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/S842 Jul 1, 2026 29d
Agilent Technologies, Inc.
 PD-L1 IHC 28-8 pharmDx Diagnostics PMA Supplement Approved P150025/S018 Jul 1, 2026 180d
Abbott Medical
 HeartMate 3™ Left Ventricular Assist System Cardiovascular PMA Supplement Approved (30-day notice) P160054/S127 Jul 1, 2026 26d
Carl Zeiss Meditec, Inc.
 MEL 90 Excimer Laser Ophthalmic PMA Supplement Approved P060004/S010 Jul 1, 2026 86d
Biotronik, Inc.
 Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16 … Cardiovascular PMA Supplement Approved (30-day notice) P980023/S148 Jul 1, 2026 16d
Biosense Webster, Inc.
 Dual Energy THERMOCOOL SMARTTOUCH SF™ System Cardiovascular PMA Supplement Approved P030031/S141 Jul 1, 2026 279d
Boston Scientific Corporation
 Bulkamid Urethral Bulking System Other PMA Supplement Approved (30-day notice) P170023/S024 Jul 1, 2026 29d
Siemens Medical Solutions USA, Inc.
 MAMMOMAT B.brilliant with Tomosynthesis Option Imaging PMA Supplement Approved P140011/S009 Jul 1, 2026 237d
Boston Scientific Corporation
 Emblem S-Icd Cardiovascular PMA Supplement Approved P110042/S211 Jul 1, 2026 89d
Boston Scientific
 Ingenio Mri, Vitalio Mri, Formio Mri, Essentio Mri, Proponent Mri, Accolade Mri Cardiovascular PMA Supplement Approved P150012/S182 Jul 1, 2026 89d
Medtronic Neuromodulation
 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and … Neurology PMA Supplement Approved P840001/S623 Jul 1, 2026 86d
Boston Scientific Corp
 Cognis, Energen, Punctua, INCepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigiliant Cardiovascular PMA Supplement Approved P010012/S607 Jul 1, 2026 89d
Boston Scientific
 Teligen, Energen, Punctua, INCepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva Cardiovascular PMA Supplement Approved P960040/S513 Jul 1, 2026 89d
Proverum, Ltd.
 ProVee System for BPH Other PMA Supplement Approved (30-day notice) P250011/S004 Jul 1, 2026 27d
Guidant Corp.
 Invive, Intua, Visionist, Valitude Cardiovascular PMA Supplement Approved P030005/S253 Jul 1, 2026 89d
Boston Scientific Corp
 ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 Cardiovascular PMA Supplement Approved N970003/S307 Jul 1, 2026 89d
Boston Scientific Corporation
 Emblem S-ICD (A209); Emblem MRI S-ICD (A219) Cardiovascular PMA Supplement Approved (30-day notice) P110042/S214 Jul 1, 2026 30d
W. L. Gore & Associates, Inc.
 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Cardiovascular PMA Supplement Approved P230023/S012 Jul 1, 2026 30d
Biotronik, Inc.
 Solia T 53, Solia T 60, Solia S 45, Solia S 53, Solia S 60, Solia CSP S 53, Solia CSP S 60 Cardiovascular PMA Supplement Approved (30-day notice) P950037/S295 Jul 1, 2026 16d
Zima International Inc., dba Dandy
 Dandy Ceramic Stain and Glaze Dental 510(k) Cleared K262195 Jun 30, 2026 1d
Ceribell, Inc.
 Ceribell Monitor Neurology 510(k) Cleared K261101 Jun 30, 2026 89d
Microvention Inc. d/b/a Terumo Neuro
 ISAAC Neurovascular Navigation Catheter Cardiovascular 510(k) Cleared K261808 Jun 30, 2026 29d
Universal Brain
 UB ERP System Neurology 510(k) Cleared K253767 Jun 30, 2026 217d
Imricor Medical Systems, Inc.
 NorthStar Mapping System (MAP01 or MAP01-01) Cardiovascular 510(k) Cleared K261119 Jun 30, 2026 88d
MeVis Medical Solutions AG
 MeVis AVM Contour Imaging 510(k) Cleared K260576 Jun 30, 2026 130d
Serpex Medical
 Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) Surgical 510(k) Cleared K261068 Jun 30, 2026 90d
Medtronic, Inc.
 PulseSelect Pulse Field Ablation (PFA) Catheter Cardiovascular PMA Supplement Approved (30-day notice) P230017/S011 Jun 30, 2026 29d
Edwards Lifesciences, LLC
 Edwards Commander Delivery System (9600LDS20; 9600LDS23; 9600LDS26; 9600LDS29) Cardiovascular PMA Supplement Approved (30-day notice) P200015/S078 Jun 30, 2026 25d
Biosense Webster, Inc.
 VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU) Cardiovascular PMA Supplement Approved P240006/S016 Jun 30, 2026 90d
Biosense Webster, Inc.
 VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System Cardiovascular PMA Supplement Approved P030031/S143 Jun 30, 2026 90d
Abbott Medical
 Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) Neurology PMA Supplement Approved P150004/S095 Jun 30, 2026 90d
Edwards Lifesciences, LLC
 Edwards Commander Delivery System (9600LDS20; 9600LDS23; 9600LDS26; 9600LDS29; 9750CM20; 9750CM23; 9750CM26 … Cardiovascular PMA Supplement Approved (30-day notice) P140031/S205 Jun 30, 2026 25d
Amann Girrbach AG
 Zolid Lunaris Dental 510(k) Cleared K260918 Jun 29, 2026 102d
Agada Medical, Ltd.
 Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) Imaging 510(k) Cleared K253628 Jun 29, 2026 222d
Cynosure Lutronic Technology Corporation
 Lutronic Genius Surgical 510(k) Cleared K253484 Jun 29, 2026 255d
Guangdong Newdermo Biotech Co., Ltd.
 LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) Surgical 510(k) Cleared K261052 Jun 29, 2026 90d
Stryker GmbH
 Pangea Femur Reconstruction System Orthopedic 510(k) Cleared K261481 Jun 29, 2026 55d
Guilin Kevin Peter Technology Co., Ltd.
 Injectable Root Canal Sealer (KP-Root SP) Dental 510(k) Cleared K261415 Jun 29, 2026 60d
Insulet Corporation
 Omnipod 6 algorithm Diagnostics 510(k) Cleared K261461 Jun 29, 2026 56d
Sterilmed, Inc.
 Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) … Cardiovascular 510(k) Cleared K254149 Jun 29, 2026 189d
New Deantronics Taiwan , Ltd.
 Irrigation Tubing Bipolar Cord Set Surgical 510(k) Cleared K251492 Jun 29, 2026 410d
Philips Ultrasound, LLC
 Alturion Series Diagnostic Ultrasound System Imaging 510(k) Cleared K260667 Jun 29, 2026 119d
Adas3D Medical S.L.
 Adas 3D Imaging 510(k) Cleared K253969 Jun 29, 2026 200d
Saluda Medical Pty, Ltd.
 Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042) Neurology PMA Supplement Approved P190002/S038 Jun 29, 2026 465d
Depuy, Inc.
 LCS® Total Knee System Orthopedic PMA Supplement Approved P830055/S367 Jun 29, 2026 26d
Saluda Medical Pty, Ltd.
 CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA) … Neurology PMA Supplement Approved P190002/S039 Jun 29, 2026 454d
Shockwave Medical, Inc.
 Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary IVL Catheter Cardiovascular PMA Supplement Approved (30-day notice) P200039/S023 Jun 29, 2026 27d
Time IS Brain, S.L.
 BraiN20® (BraiN20) Neurology 510(k) Cleared K253301 Jun 27, 2026 271d
Imagine Milling Technologies, LLC
 Mist Ic Dental 510(k) Cleared K261122 Jun 27, 2026 85d
Honeynaps Co., Ltd.
 Somnum (Somnum) Neurology 510(k) Cleared K253390 Jun 27, 2026 270d
Silony Medical GmbH
 VERTICALE® Navigation Instruments Neurology 510(k) Cleared K253921 Jun 26, 2026 200d
Cadwell Industries, Inc.
 Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array Neurology 510(k) Cleared K261442 Jun 26, 2026 57d
Phast Corp.
 PhAST instrument and PhAST Blood Culture Gram-negative Panel Diagnostics 510(k) Cleared K253316 Jun 26, 2026 269d
BioHorizons Implant Systems, Inc.
 BioHorizons CEREC Compatible Ti-Bases Dental 510(k) Cleared K260061 Jun 26, 2026 169d
Ziree Co., Ltd.
 Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1 … Physical Medicine 510(k) Cleared K261253 Jun 26, 2026 71d
Biotracker, LLC
 BioTracker 2.0 Other 510(k) Cleared K253306 Jun 26, 2026 270d
Shenzhen Changkun Technology Co., Ltd.
 Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) Women's Health 510(k) Cleared K250070 Jun 26, 2026 532d
Bonebridge AG
 SALGINA 2.5mm Distal Radius System Orthopedic 510(k) Cleared K261351 Jun 26, 2026 63d
Spectrum Vascular
 Arterial Pressure Monitoring Set/Tray Cardiovascular 510(k) Cleared K261455 Jun 26, 2026 56d
Therapixel
 MammoScreen® (5) Imaging 510(k) Cleared K260714 Jun 26, 2026 113d
ElectroWire Medical
 LightningWire Transseptal Puncture System (TPS) Cardiovascular 510(k) Cleared K261745 Jun 26, 2026 30d
Edwards Lifesciences
 ECLIPTIS Left Atrial Appendage Exclusion System (ECS135) … Surgical 510(k) Cleared K254232 Jun 26, 2026 179d
Abbott Point of Care, Inc.
 i-STAT Crea cartridge with the i-STAT 1 System Diagnostics 510(k) Cleared K261039 Jun 26, 2026 88d
Shenzhen Dongdixin Technology Co., Ltd.
 TENS 7000 Rechargeable 4 Channel (TENS 7000H) Neurology 510(k) Cleared K260412 Jun 26, 2026 137d
Arthrex, Inc.
 Arthrex FiberButton Orthopedic 510(k) Cleared K260018 Jun 26, 2026 172d
Abbott Medical
 Tendril STS Leads; Ultipace Leads; Optisense Leads Cardiovascular PMA Supplement Approved (30-day notice) P960013/S134 Jun 26, 2026 28d
Stryker Neurovascular
 Surpass Evolve; Surpass Elite FDS Neurology PMA Supplement Approved (30-day notice) P170024/S026 Jun 26, 2026 29d
Abbott Medical
 Durata Leads; Optisure Leads; UltiSync Leads Cardiovascular PMA Supplement Approved (30-day notice) P950022/S154 Jun 26, 2026 28d
Abbott Medical
 IsoFlex Leads Cardiovascular PMA Supplement Approved (30-day notice) P960030/S085 Jun 26, 2026 28d
Merz North America, Inc.
 RADIESSE® Injectable Implant Surgical PMA Supplement Approved (30-day notice) P050037/S154 Jun 26, 2026 29d
Artivion, Inc.
 AMDS Hybrid Prosthesis Cardiovascular PMA Approved P250055 Jun 26, 2026 179d
Rxsight, Inc.
 RxSight Light Adjustable Lens; Light Delivery Device Ophthalmic PMA Supplement Approved P160055/S054 Jun 26, 2026 269d
Merz North America, Inc.
 COAPTITE® Agent, Bulking, Injectable For Gastro-Urology Use Other PMA Supplement Approved (30-day notice) P040047/S083 Jun 26, 2026 29d
Merz North America, Inc.
 RADIESSE® Injectable Implant Surgical PMA Supplement Approved (30-day notice) P050052/S179 Jun 26, 2026 29d
Farapulse, Inc.
 FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter … Cardiovascular PMA Supplement Approved (30-day notice) P230030/S023 Jun 26, 2026 9d
Illumina, Inc.
 TruSight Oncology Comprehensive Diagnostics PMA Supplement Approved P230011/S002 Jun 26, 2026 512d
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
 Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield) … Neurology PMA Supplement Approved (30-day notice) P100018/S054 Jun 26, 2026 29d
Longeviti Neuro Solutions
 ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752) … Neurology 510(k) Cleared K260709 Jun 25, 2026 113d
Seers Technology Co., Ltd.
 mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) Cardiovascular 510(k) Cleared K253384 Jun 25, 2026 268d
Pendracare
 SimplGuide Cardiovascular 510(k) Cleared K261242 Jun 25, 2026 71d
Uniqa Dental, Ltd.
 UNIQA® Dental Implants System Dental 510(k) Cleared K251188 Jun 25, 2026 434d
GN Hearing A/S
 Jabra Enhance Select Self-fit (Jabra Enhance Select 550) Other 510(k) Cleared K254108 Jun 25, 2026 188d
Neuralytix
 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) Other 510(k) Cleared K260992 Jun 25, 2026 91d
Shenzhen Qinyi Electronic Technology Co., Ltd.
 Wearable breast pump (QY-101, QY-102, QY-108) Women's Health 510(k) Cleared K261025 Jun 25, 2026 87d
Weyo Surgical Technology , Ltd.
 Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) Women's Health 510(k) Cleared K252584 Jun 25, 2026 314d
DePuy Ireland UC
 ATTUNE Total Knee System; ATTUNE Cementless Knee System Orthopedic 510(k) Cleared K261458 Jun 25, 2026 55d
Depuy Ireland UC
 VELYS™ Robotic-Assisted Solution Neurology 510(k) Cleared K260480 Jun 25, 2026 132d
ASESSO HEALTH, Inc.
 G-Series Grind Guard Other 510(k) Cleared K260790 Jun 25, 2026 106d
Phadia AB
 EliA CTD 13 Screen Diagnostics 510(k) Cleared K253367 Jun 25, 2026 268d
Arthrex, Inc.
 Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System Orthopedic 510(k) Cleared K260809 Jun 25, 2026 105d
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
 A5 Anesthesia System (A5); A7 Anesthesia System (A7) Anesthesiology 510(k) Cleared K253330 Jun 25, 2026 268d
ETHICON, Inc.
 Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture Surgical 510(k) Cleared K253394 Jun 25, 2026 268d
Alphatec Spine, Inc.
 IntraOp Alignment System; CONTOUR3D Bending System Orthopedic 510(k) Cleared K253216 Jun 25, 2026 269d
Siemens Medical Solutions USA, Inc.
 syngo.CT Coronary Cockpit Imaging 510(k) Cleared K253786 Jun 25, 2026 211d
Vistar Medical Supplies Co., Ltd.
 DVT Garment Cardiovascular 510(k) Cleared K253386 Jun 25, 2026 268d
Intelligent Dots, LLC
 BedDot (G1) Anesthesiology 510(k) Cleared K253274 Jun 25, 2026 269d
Apryse Software Corp
 MiPACS V5 (1.0.0) Imaging 510(k) Cleared K260231 Jun 25, 2026 150d
ETHICON, Inc.
 SURGICEL® Absorbable Hemostats Surgical PMA Supplement Approved (30-day notice) N12159/S130 Jun 25, 2026 22d
Physio-Control, Inc.
 LIFEPAK® 15 monitor/defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P160026/S068 Jun 25, 2026 23d
Abbott Medical
 TriClip Systems Cardiovascular PMA Supplement Approved (30-day notice) P230007/S023 Jun 25, 2026 27d
Merz North America, Inc.
 Belotero Volume (+) Lidocaine Dermal Filler Surgical PMA Supplement Approved (30-day notice) P250020/S002 Jun 25, 2026 30d
ETHICON, Inc.
 GYNECARE INTERCEED™ Absorbable Adhesion Barrier Women's Health PMA Supplement Approved (30-day notice) P880047/S070 Jun 25, 2026 22d
ETHICON, Inc.
 ETHIZIA Hemostatic Patch Surgical PMA Supplement Approved P240035/S002 Jun 25, 2026 178d
Medtronic, Inc.
 Aurora EV ICD DVEA3E4 Cardiovascular PMA Supplement Approved P220012/S069 Jun 25, 2026 87d
Medtronic Cardiac Rhythm Disease Management
 Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava Quad CRT-D DTBC1Q1 … Cardiovascular PMA Supplement Approved P010031/S922 Jun 25, 2026 87d
Medtronic Cardiac Rhythm Disease Management
 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR … Cardiovascular PMA Supplement Approved P980016/S955 Jun 25, 2026 87d
Abbott Medical
 MitraClip Systems Cardiovascular PMA Supplement Approved (30-day notice) P100009/S086 Jun 25, 2026 27d
Defibtech, LLC
 Defibtech Automated External Defibrillator (AED) Systems Cardiovascular PMA Supplement Approved P160032/S016 Jun 25, 2026 9d
Shanghai Waylong Intelligent Technology Co.,Ltd
 Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) Physical Medicine 510(k) Cleared K260937 Jun 24, 2026 96d
Ge Medical Systems, LLC
 Enhanced Boundary for PCCT Imaging 510(k) Cleared K253560 Jun 24, 2026 219d
Sonoma Pharmaceuticals, Inc.
 Microdacyn Wound Irrigation Solution Other 510(k) Cleared K261023 Jun 24, 2026 86d
Stryker Neurovscular
 Target Xtra Detachable Coil Neurology 510(k) Cleared K261772 Jun 24, 2026 26d
Hangzhou AGS MedTech Co., Ltd.
 Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 … Other 510(k) Cleared K253393 Jun 24, 2026 267d
Insera Therapeutics, Inc.
 CLEAR™ Aspiration System Other 510(k) Cleared K253404 Jun 24, 2026 267d
STERIS Corporation
 AMSCO 700 Steam Sterilizer General Hospital 510(k) Cleared K261055 Jun 24, 2026 85d
Sw Technologies, Inc.
 Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs … General Hospital 510(k) Cleared K252117 Jun 24, 2026 352d
Convatec Limited, Gdc Building
 ConvaVAC™ Negative Pressure Wound Therapy System Surgical 510(k) Cleared K253263 Jun 24, 2026 268d
Ceribell, Inc.
 Ceribell Neurology Review Software Neurology 510(k) Cleared K260998 Jun 24, 2026 90d
Olympus Medical Systems Corporation
 HD Camera Head OLYMPUS CH-S200-08-LB Other 510(k) Cleared K261260 Jun 24, 2026 69d
Hangzhou Jimushi Meditech Co., Ltd.
 Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) Other 510(k) Cleared K260394 Jun 24, 2026 138d
Silverceuticals, Inc.
 SilverCeuticals® Antimicrobial Wound Gel Other 510(k) Cleared K251929 Jun 24, 2026 366d
Medtronic, Inc.
 Concerto Versa™ Detachable Coil Cardiovascular 510(k) Cleared K261866 Jun 24, 2026 20d
Aroa Biosurgery , Ltd.
 Endoform Dermal Template Other 510(k) Cleared K260669 Jun 24, 2026 114d
Biotronik, Inc.
 Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015) … Cardiovascular PMA Supplement Approved (30-day notice) P980023/S147 Jun 24, 2026 28d
Biotronik, Inc.
 Acticor 7 VR-T DX (429525); Acticor 7 VR-T DF4 ProMRI (429526); Rivacor 3 VR-T DF4 ProMRI (429574) … Cardiovascular PMA Supplement Approved (30-day notice) P050023/S212 Jun 24, 2026 28d
Vascutek, Ltd.
 Thoraflex™ Hybrid Cardiovascular PMA Supplement Approved (30-day notice) P210006/S019 Jun 24, 2026 29d
Medtronic, Inc.
 CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B) Cardiovascular PMA Supplement Approved (30-day notice) P930039/S278 Jun 24, 2026 28d
Medtronic, Inc.
 Sprint Quattro Lead (6946M) Cardiovascular PMA Supplement Approved (30-day notice) P920015/S306 Jun 24, 2026 28d
Keri Medical SA
 TOUCH® CMC 1 Prosthesis Orthopedic PMA Supplement Approved (30-day notice) P240020/S006 Jun 24, 2026 22d
Shockwave Medical, Inc.
 Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL … Cardiovascular PMA Supplement Approved P200039/S021 Jun 24, 2026 77d
DiaSorin, Inc.
 LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus Diagnostics PMA Supplement Approved (30-day notice) P220034/S011 Jun 24, 2026 20d
Medtronic, Inc.
 Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598) … Cardiovascular PMA Supplement Approved (30-day notice) P080006/S193 Jun 24, 2026 28d
DiaSorin, Inc.
 LIAISON® Biotrin Parvovirus B19 IgM Plus, LIAISON® Biotrin Control Parvovirus B19 IgM Plus Diagnostics PMA Supplement Approved (30-day notice) P250039/S001 Jun 24, 2026 20d
Medtronic Cardiac Rhythm Disease Management
 CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB) Cardiovascular PMA Supplement Approved (30-day notice) P830061/S236 Jun 24, 2026 28d
Medtronic Cardiac Rhythm Disease Management
 SelectSecure Lead (3830) Cardiovascular PMA Supplement Approved (30-day notice) P030036/S160 Jun 24, 2026 28d
Biotronik, Inc.
 Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014) Cardiovascular PMA Supplement Approved (30-day notice) P000009/S131 Jun 24, 2026 28d
Integra Lifesciences Production Corporation
 Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) … Neurology 510(k) Cleared K261004 Jun 23, 2026 89d
CG Bio Co., Ltd.
 Curasys 2 (Emdn0003) Surgical 510(k) Cleared K253199 Jun 23, 2026 270d
Microlife Corporation
 Microlife Digital Peak Flow Meter, Model PF200B (PF200B) Anesthesiology 510(k) Cleared K253180 Jun 23, 2026 270d
Procept Biorobotics
 AQUABEAM Robotic System Surgical 510(k) Cleared K253211 Jun 23, 2026 267d
Cordis US Corporation
 Exoseal Vascular Closure Device Cardiovascular PMA Supplement Approved P100013/S034 Jun 23, 2026 25d
W. L. Gore & Associates, Inc.
 GORE® EXCLUDER® AAA Endoprosthesis Cardiovascular PMA Supplement Approved (30-day notice) P020004/S208 Jun 23, 2026 25d
Merz North America, Inc.
 Belotero Volume (+) Lidocaine Surgical PMA Supplement Approved (30-day notice) P250020/S003 Jun 23, 2026 26d
Kardium, Inc.
 Globe® Catheter and Globe® Pulsed Field System Cardiovascular PMA Supplement Approved P240044/S001 Jun 23, 2026 267d
Prodeon Medical, Inc.
 Urocross Expander System (UES-2018-C1) Other 510(k) Cleared K261342 Jun 22, 2026 60d
Quantified Imaging Limited
 Perfusion Measurement Platform v1 Imaging 510(k) Cleared K253421 Jun 22, 2026 264d
LBDO Group, Inc.
 Flow Water-Based Personal Lubricant Women's Health 510(k) Cleared K254011 Jun 22, 2026 189d
Health Line International Corporation
 Health Line Tearaway Introducer Cardiovascular 510(k) Cleared K261950 Jun 22, 2026 12d
Vivaquant, Inc. Dba Rhythm Express
 RX-1 Sleep Anesthesiology 510(k) Cleared K253148 Jun 22, 2026 270d
Medline Industries, LP
 Medline Reusable Blood Pressure Cuff Cardiovascular 510(k) Cleared K254287 Jun 22, 2026 173d
Beyond 700 Pty, Ltd.
 TearView Ophthalmic 510(k) Cleared K253176 Jun 22, 2026 269d
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
 Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) Physical Medicine 510(k) Cleared K261076 Jun 22, 2026 82d
Nexus Spine
 DeltaNEC Interbody System Orthopedic 510(k) Cleared K261279 Jun 22, 2026 66d
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
 Manual Wheelchair (MS01);Manual Wheelchair (MA01) Physical Medicine 510(k) Cleared K261075 Jun 22, 2026 82d
Cercare Medical A/S
 CMN Capillary Function with Oncology Virtual Expert Imaging 510(k) Cleared K260316 Jun 22, 2026 143d
Biotronik AG
 Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System Cardiovascular PMA Supplement Approved (30-day notice) P160025/S025 Jun 22, 2026 12d
Lungpacer Medical USA, Inc.
 AeroPace® System Anesthesiology PMA Supplement Approved P240012/S006 Jun 22, 2026 81d
Abbott Molecular, Inc.
 Alinity m HR HPV Diagnostics PMA Supplement Approved (30-day notice) P230003/S018 Jun 22, 2026 27d
Heartsine Technologies, Ltd.
 HeartSine® samaritan® (SAM) Public Access Defibrillator (PAD) SAM 350P, SAM 360P and SAM 450P and Accessories Cardiovascular PMA Supplement Approved (30-day notice) P160008/S035 Jun 22, 2026 14d
Lung Bioengineering, Inc.
 Centralized Lung Evaluation System (CLES) Other PMA Approved P240033 Jun 22, 2026 630d
Lungpacer Medical USA, Inc.
 AeroPace® System Anesthesiology PMA Supplement Approved P240012/S007 Jun 22, 2026 27d
Bard Peripheral Vascular, Inc.
 Fluency™ Plus Endovascular Stent Graft Cardiovascular PMA Supplement Approved (30-day notice) P130029/S015 Jun 22, 2026 26d
Abbott Medical
 Volt™ Pfa Catheter, Sensor Enabled™ Cardiovascular PMA Supplement Approved (30-day notice) P250022/S007 Jun 22, 2026 25d
Biotronik AG
 Astron Peripheral Self-Expanding Nitinol Stent System Cardiovascular PMA Supplement Approved (30-day notice) P140030/S024 Jun 22, 2026 12d
Q-Med AB
 SCULPTRA® (injectable poly-L Lactic acid) Surgical PMA Supplement Approved (30-day notice) P030050/S055 Jun 22, 2026 26d
Abbott Medical
 Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves Cardiovascular PMA Supplement Approved P040021/S061 Jun 22, 2026 182d
LEM Surgical AG
 Dynamis Robotic Surgical System Neurology 510(k) Cleared K260369 Jun 20, 2026 135d
Kanglongda Vietnam Protection Technology Company Limited
 Powder Free Nitrile Examination Gloves Non-Sterile Black General Hospital 510(k) Cleared K253824 Jun 18, 2026 199d
Sol-Millennium Medical, Inc.
 Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe General Hospital 510(k) Cleared K253110 Jun 18, 2026 267d
Corcym S.r.l.
 MEMO 4D Curve™ Semirigid mitral annuloplasty ring Cardiovascular 510(k) Cleared K261707 Jun 18, 2026 27d
Zywie, Inc.
 ZywieZ3 Sensor & Adhesive Cardiovascular 510(k) Cleared K252839 Jun 18, 2026 286d
Autonomous Healthcare, Inc.
 Syncron-E Anesthesiology De Novo Granted DEN250025 Jun 18, 2026 360d
Mastel Surgical
 SteriBest® Sterilization Tray System General Hospital 510(k) Cleared K253187 Jun 18, 2026 265d
Presage Security, Inc. d/b/a Presage Technologies, Inc.
 SmartSpectra Vital Signs Monitor 1.0 Cardiovascular 510(k) Cleared K254169 Jun 18, 2026 177d
Daxor Corporation
 Blood Volume Analyzer (200) Diagnostics 510(k) Cleared K261099 Jun 18, 2026 77d
Guangdong Newdermo Biotech Co., Ltd.
 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) Surgical 510(k) Cleared K260946 Jun 18, 2026 87d
Micro-Energy Medical Technology Co., Ltd.
 Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) Surgical 510(k) Cleared K261701 Jun 18, 2026 27d
Providence Medical Technology, Inc.
 CORUS™ Navigation System-GN Neurology 510(k) Cleared K261665 Jun 18, 2026 29d
Avalign Technologies, Inc.
 CONDUIT™ ZERO-P™ VA Secured Spacer System Orthopedic 510(k) Cleared K252982 Jun 18, 2026 274d
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
 Power Wheelchair (W5915B, W5915C, W5915D) Physical Medicine 510(k) Cleared K253812 Jun 18, 2026 202d
ROPCA ApS
 Arthur Imaging 510(k) Cleared K260190 Jun 18, 2026 147d
Guangzhou Rebornendo Medical Instrument Co., Ltd.
 Curing Light (M-Cure 6) Dental 510(k) Cleared K253131 Jun 18, 2026 266d
True Indicating, LLC
 InstaTRU Instant Biological Indicator for Steam (IBI-05) General Hospital 510(k) Cleared K251559 Jun 18, 2026 393d
Vincent Healthcare Products Limited
 inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009) … Anesthesiology 510(k) Cleared K252066 Jun 18, 2026 352d
The Surgeon General, Department of the Army (TSG-DA)
 3D MAC Titanium Cranial Plate (TCP) System Neurology 510(k) Cleared K253116 Jun 18, 2026 267d
Informai
 RadOncAI Imaging 510(k) Cleared K253050 Jun 18, 2026 269d
Megagen Implant Co., Ltd.
 MegaGen Zygoma Dental Implant System Dental 510(k) Cleared K251232 Jun 18, 2026 422d
Shantou Institute of Ultrasonic Instruments Co., Ltd.
 Portable DR Imaging System Imaging 510(k) Cleared K253058 Jun 18, 2026 269d
Ecm Therapeutics, Inc.
 Ecmt-100 Wmd Other 510(k) Cleared K253521 Jun 18, 2026 217d
Shenzhen Konmed Technology Co., Ltd.
 Pelvic Muscle Trainer (KM510, KM516B) Other 510(k) Cleared K260178 Jun 18, 2026 148d
Hycor Biomedical
 NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum) … Diagnostics 510(k) Cleared K260280 Jun 18, 2026 140d
Vieworks Co., Ltd.
 Vivix-S 4386W (Fxrd-4386Wa) Imaging 510(k) Cleared K260820 Jun 18, 2026 97d
Stryker Sustainability Solutions
 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating Surgical 510(k) Cleared K260636 Jun 18, 2026 112d
Shenzhen Root Innovation Technology Co., Ltd.
 Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) Women's Health 510(k) Cleared K254254 Jun 18, 2026 171d
Shenzhen Ziqing Medical Equipment Co., Ltd.
 Wrist Blood Pressure Monitor (XW-05) Cardiovascular 510(k) Cleared K253126 Jun 18, 2026 266d
GuideAI Health
 Vascular Assist Occlusion Triage (VAOT) (v1.0) Imaging 510(k) Cleared K260729 Jun 18, 2026 104d
W&H Dentalwerk Buermoos GmbH
 Implantmed Plus II & Piezomed Plus II Module Dental 510(k) Cleared K253776 Jun 18, 2026 204d
FUJIFILM Healthcare Americas Corporation
 Synapse PACS (7.6.0) Imaging 510(k) Cleared K261713 Jun 18, 2026 27d
GC America, Inc.
 Srgc-06 Dental 510(k) Cleared K261246 Jun 18, 2026 63d
Siemens Medical Solutions USA, Inc.
 MAMMOMAT B.brilliant (11372950) Imaging 510(k) Cleared K253678 Jun 18, 2026 209d
A.B. Dental Devices , Ltd.
 Dental Implant System Dental 510(k) Cleared K250806 Jun 18, 2026 458d
NuVasive Specialized Orthopedics
 Precice™ Max System and Precice™ Ankle Salvage System Orthopedic 510(k) Cleared K261651 Jun 18, 2026 30d
Suzhou and Science & Technology Development Corp.
 AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) Orthopedic 510(k) Cleared K253080 Jun 18, 2026 268d
Edwards Lifesciences, LLC
 PASCAL Precision Transcatheter Valve Repair System Cardiovascular PMA Supplement Approved (30-day notice) P220003/S030 Jun 18, 2026 27d
Mobia Medical, Inc.
 Vivistim Pair VNS System Physical Medicine PMA Supplement Approved (30-day notice) P210007/S014 Jun 18, 2026 27d
Bolton Medical, Inc.
 RelayPro Thoracic Stent-Graft System Cardiovascular PMA Supplement Approved (30-day notice) P200045/S024 Jun 18, 2026 29d
LivaNova USA, Inc.
 aura6000™ system Anesthesiology PMA Supplement Approved P250013/S002 Jun 18, 2026 30d
Bolton Medical, Inc.
 TREO® Abdominal Stent-Graft System Cardiovascular PMA Supplement Approved (30-day notice) P190015/S030 Jun 18, 2026 29d
Hepquant, LLC
 HepQuant SHUNT® Liver Diagnostic Test Diagnostics PMA Approved P220016 Jun 18, 2026 1373d
Cynosure, LLC
 Picosure Workstation Surgical 510(k) Cleared K261570 Jun 17, 2026 36d
Inosys, Inc.
 INOSS System Dental 510(k) Cleared K260006 Jun 17, 2026 166d
Hartalega NGC Sdn. Bhd.
 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) … General Hospital 510(k) Cleared K260867 Jun 17, 2026 92d
Stryker Instruments
 Hydro Irrigation System Other 510(k) Cleared K261544 Jun 17, 2026 40d
Shenzhen Root Innovation Technology Co., Ltd.
 Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) Women's Health 510(k) Cleared K260538 Jun 17, 2026 120d
Nordic Kinetics AB
 Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) Neurology 510(k) Cleared K253055 Jun 17, 2026 268d
Portal Access, Inc.
 FLEXI-PORT™ Power Injectable Implantable Port General Hospital 510(k) Cleared K260916 Jun 17, 2026 90d
Deka Research and Development
 twiist Automated Insulin Delivery (AID) System Diagnostics 510(k) Cleared K261672 Jun 17, 2026 27d
Socko Medical Co., Ltd.
 “Socko” Vimax Spinal Fixation System Orthopedic 510(k) Cleared K253045 Jun 17, 2026 268d
Foshan Pingchuang Medical Technology Co., Ltd.
 Non-Sterile Ultrasound Gel Sterile Ultrasound Gel Imaging 510(k) Cleared K253255 Jun 17, 2026 261d
Beijing Fule Science & Technology Development Co., Ltd.
 Fule Metallic Lockable Intramedullary Nail Systems Orthopedic 510(k) Cleared K253155 Jun 17, 2026 264d
Abbott Medical
 Amplatzer TorqVue Exchange System Cardiovascular 510(k) Cleared K261631 Jun 17, 2026 30d
Oneness Biotech Co., Ltd.
 Bonvadis® Other 510(k) Cleared K261638 Jun 17, 2026 30d
Hologic, Inc.
 CoolSeal Generator® (CSL-200-90) Surgical 510(k) Cleared K253634 Jun 17, 2026 210d
Boston Scientific Corporation
 RIVOS™ EUS Access Device (M00553900) Other 510(k) Cleared K260428 Jun 17, 2026 127d
Honsun (Nantong) Co., Ltd.
 Portable Oxygen Concentrator Anesthesiology 510(k) Cleared K252399 Jun 17, 2026 321d
Hua Yue Medical Technology Co., Ltd.
 Assisted Reproduction Laser System (Model ILS-400M) Women's Health 510(k) Cleared K253333 Jun 17, 2026 260d
Ferrosan Meidcal Devices A/S
 SURGIFOAM® Absorbable Gelatin Sponge Surgical PMA Supplement Approved (30-day notice) P990004/S081 Jun 17, 2026 26d
Pulmonx Corporation
 Zephyr Endobronchial Valve (EBV) System Anesthesiology PMA Supplement Approved (30-day notice) P180002/S031 Jun 17, 2026 26d
NeuroPace, Inc.
 NeuroPace® RNS® System Neurology PMA Supplement Approved P100026/S100 Jun 17, 2026 328d
Boston Scientific Corporation
 Axonics SNM System Other PMA Supplement Approved (30-day notice) P180046/S112 Jun 17, 2026 27d
Abbott Medical
 AVEIR Patient Transmitter LSRM01 Cardiovascular PMA Supplement Approved (30-day notice) P150035/S040 Jun 17, 2026 29d
Merz North America, Inc.
 Belotero Volume (+) Lidocaine Surgical PMA Supplement Approved (30-day notice) P250020/S001 Jun 17, 2026 28d
Boston Scientific Corporation
 Axonics SNM System Other PMA Supplement Approved (30-day notice) P190006/S112 Jun 17, 2026 27d
Hunan Ruijiong Biotech Co., Ltd.
 KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) Anesthesiology 510(k) Cleared K253001 Jun 16, 2026 270d
Wright Medical Technology, Inc. (Stryker)
 Prophecy Incompass Surgical Planning System Orthopedic 510(k) Cleared K253159 Jun 16, 2026 263d
Fujifilm Corporation
 FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T Other 510(k) Cleared K253137 Jun 16, 2026 264d
Zdeer Technology (Henan) Co., Ltd.
 Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) Physical Medicine 510(k) Cleared K260899 Jun 16, 2026 90d
Zimmer, Inc.
 Z1 Hip System Orthopedic 510(k) Cleared K260831 Jun 16, 2026 95d
Hubei Yjt Technology Co.,Ltd
 Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552 … Physical Medicine 510(k) Cleared K253231 Jun 16, 2026 260d
Empirical Spine
 LimiFlex® Dynamic Sagittal Tether Instrument Set Orthopedic 510(k) Cleared K253374 Jun 16, 2026 259d
ZheJiang Decans Medical Devices Co., Ltd.
 HERA Interlocking Intramedullary Nailing System Orthopedic 510(k) Cleared K253046 Jun 16, 2026 267d
Neurent Medical , Ltd.
 NEUROMARK System (NMK00301) Surgical 510(k) Cleared K261833 Jun 16, 2026 14d
I.T.S. GmbH
 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability … Orthopedic 510(k) Cleared K260958 Jun 16, 2026 85d
Hivox Biotek, Inc.
 TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) Neurology 510(k) Cleared K260425 Jun 16, 2026 126d
80 Beats Medical GmbH
 VicorderCS (VCS-SYS-1100) Cardiovascular 510(k) Cleared K260693 Jun 16, 2026 105d
Diazyme Laboratories, Inc.
 Lipoprotein (a) Molarity Assay Diagnostics 510(k) Cleared K253069 Jun 16, 2026 266d
Medpark Co., Ltd.
 BOSS Dental 510(k) Cleared K253723 Jun 16, 2026 204d
Siemens Healthcare GmbH
 myAblation Guide (VC10A) Imaging 510(k) Cleared K253264 Jun 16, 2026 260d
Siemens Medical Solutions USA, Inc.
 ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System … Imaging 510(k) Cleared K260844 Jun 16, 2026 92d
Shenzhen Kaiyan Medical Equipment Co., Ltd.
 LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) Surgical 510(k) Cleared K254025 Jun 16, 2026 182d
Zimmer, Inc.
 Augment Off-Axis Instrument System Orthopedic 510(k) Cleared K261683 Jun 16, 2026 26d
Medtronic Neuromodulation
 Altaviva™ Other PMA Supplement Approved (30-day notice) P240011/S014 Jun 16, 2026 19d
Medtronic, Inc.
 Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ Neurology PMA Supplement Approved (30-day notice) P960009/S537 Jun 16, 2026 19d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P970004/S454 Jun 16, 2026 19d
Kaneka Pharma America Corp.
 LIPOSORBER® LA-15 System Other PMA Supplement Approved (30-day notice) P910018/S042 Jun 16, 2026 21d
W. L. Gore & Associates, Inc.
 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Cardiovascular PMA Supplement Approved (30-day notice) P160021/S052 Jun 16, 2026 25d
Roche Molecular Systems, Inc.
 cobas HPV Diagnostics PMA Supplement Approved P190028/S023 Jun 16, 2026 162d
Medtronic Neuromodulation
 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and … Neurology PMA Supplement Approved (30-day notice) P840001/S629 Jun 16, 2026 19d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P080025/S349 Jun 16, 2026 19d
Defibtech, LLC
 Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO … Cardiovascular PMA Supplement Approved P160032/S015 Jun 16, 2026 291d
CooperVision, Inc.
 comflicon A Soft (Hydrophilic) Contact Lenses for Extended Wear Ophthalmic PMA Supplement Approved (30-day notice) P080011/S202 Jun 16, 2026 29d
Diasorin Molecular, LLC
 LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit Diagnostics 510(k) Cleared K260333 Jun 15, 2026 133d
Tournicare Pty, Ltd.
 Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) Cardiovascular 510(k) Cleared K253059 Jun 15, 2026 266d
Zdeer Technology (Henan) Co., Ltd.
 Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156 … Other 510(k) Cleared K260452 Jun 15, 2026 124d
Beijing Fule Science & Technology Development Co., Ltd.
 Fule Interbody Fusion Cage System Orthopedic 510(k) Cleared K253151 Jun 15, 2026 262d
DeepHealth, Inc.
 Saige-Dx Imaging 510(k) Cleared K253825 Jun 15, 2026 196d
Zhongshan Sulenz Intelligent Technology Co., Ltd.
 Electric Wheelchair (S500-6) Physical Medicine 510(k) Cleared K260335 Jun 15, 2026 133d
Luma Vision Limited
 VERAFEYE Imaging and Guidance System (VF-VIS-002) Other 510(k) Cleared K260885 Jun 15, 2026 90d
Gimbo Medical Technology Shenzhen Co., Ltd.
 Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle Women's Health 510(k) Cleared K253121 Jun 15, 2026 263d
JJGC Indústria e Comércio de Materiais Dentários S.A.
 Neodent Scannable Healing Abutment Dental 510(k) Cleared K253922 Jun 15, 2026 189d
Medyssey Co, Ltd.
 NeckTune™ 3D SA Cervical Cage Orthopedic 510(k) Cleared K260036 Jun 15, 2026 160d
Siemens Healthineers AG
 LungMaps Imaging 510(k) Cleared K253690 Jun 15, 2026 206d
Orthocon, Inc.
 Permatage XT Settable Bone Putty Neurology 510(k) Cleared K261265 Jun 15, 2026 60d
Crescom Co., Ltd.
 MediAI-OA Imaging 510(k) Cleared K253172 Jun 15, 2026 262d
Jpi Healthcare Co, Ltd.
 DRE Duo Imaging 510(k) Cleared K260482 Jun 15, 2026 122d
USpharma, Ltd.
 Curajel™ Oral Gel Other 510(k) Cleared K260126 Jun 15, 2026 151d
Spine Wave, Inc.
 Dynamo™ Spinal Cement; Salvo® Spine System Orthopedic 510(k) Cleared K260286 Jun 15, 2026 137d
Anumana, Inc.
 WatchMate Software Imaging 510(k) Cleared K260300 Jun 15, 2026 136d
Proverum, Ltd.
 ProVee System for BPH Other PMA Supplement Approved (30-day notice) P250011/S003 Jun 15, 2026 28d
Abiomed, Inc.
 Impella CP with SmartAssist Cardiovascular PMA Supplement Approved P140003/S138 Jun 15, 2026 28d
Neuroelectrics Barcelona S.L.U.
 Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) Neurology 510(k) Cleared K261604 Jun 13, 2026 30d
Autonomous Medical Devices Incorporated
 Fast PCR Mini Respiratory Panel Diagnostics 510(k) Cleared K252932 Jun 12, 2026 270d
SteriLance Medical (Suzhou), Inc.
 Disposable Blood Lancet (Soft) Surgical 510(k) Cleared K261634 Jun 12, 2026 25d
Dosisoft SA
 ThinkQA 3 Imaging 510(k) Cleared K252937 Jun 12, 2026 270d
Polybell (Guangzhou) Limited
 Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) Women's Health 510(k) Cleared K260346 Jun 12, 2026 129d
Midmark Corporation
 Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) Cardiovascular 510(k) Cleared K253196 Jun 12, 2026 259d
Tyber Medical, LLC
 Exalta Proximal Tibia Plating System Orthopedic 510(k) Cleared K261207 Jun 12, 2026 60d
Stryker Corporation (Tornier, Inc.)
 Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System Orthopedic 510(k) Cleared K260102 Jun 12, 2026 150d
Roche Diagnostics
 cobas pulse blood glucose monitoring system Diagnostics 510(k) Cleared K252323 Jun 12, 2026 322d
Bayer Medical Care, Inc.
 MEDRAD® Imaging Bulk Package Transfer Spike General Hospital 510(k) Cleared K253688 Jun 12, 2026 203d
CMT Health PTE., Ltd.
 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle … General Hospital 510(k) Cleared K260514 Jun 12, 2026 115d
Lg Electronics.Inc
 Medical Monitor (40HT513D) Imaging 510(k) Cleared K261213 Jun 12, 2026 59d
Epic Medical Pte. , Ltd.
 ADRx™ Admixture Device General Hospital 510(k) Cleared K252987 Jun 12, 2026 267d
Dyne Medical Group, Inc.
 Dyne Port Other 510(k) Cleared K252933 Jun 12, 2026 270d
Micropace Pty, Ltd.
 OneStim-DUO Cardiac Stimulator (MP5003-4CO) Cardiovascular 510(k) Cleared K253088 Jun 12, 2026 262d
Nuvascular, Inc.
 HARBOR Occlusion Device Cardiovascular 510(k) Cleared K260635 Jun 12, 2026 106d
Brainomix Limited
 Brainomix 360 Hyperdensity Imaging 510(k) Cleared K260406 Jun 12, 2026 123d
Sutura Medical Technology, Inc.
 Barbed PDO Suture Surgical 510(k) Cleared K252171 Jun 12, 2026 337d
Konica Minolta Healthcare Americas, Inc.
 Universal 1417PI Imaging 510(k) Cleared K252996 Jun 12, 2026 267d
Spiro Robotics
 Spiro-VISTA Anesthesiology 510(k) Cleared K253437 Jun 12, 2026 254d
VoxNeuro, Inc.
 Cognitive Function Neuroimaging (cfNI) Software (1.0.0) Neurology 510(k) Cleared K253015 Jun 12, 2026 266d
Dexcom, Inc.
 Stelo Glucose Biosensor System Diagnostics 510(k) Cleared K260935 Jun 12, 2026 84d
BTL Industries, Inc.
 Btl-899Tt Physical Medicine 510(k) Cleared K252963 Jun 12, 2026 268d
Whill, Inc.
 WHILL (WHILL Model C2) Physical Medicine 510(k) Cleared K261175 Jun 12, 2026 63d
Somnomed, Inc.
 Virtus Dental 510(k) Cleared K261366 Jun 12, 2026 46d
Sanhe LEFIS Electronics Co., Ltd.
 Intense Pulsed Light Therapy Device Surgical 510(k) Cleared K261204 Jun 12, 2026 60d
Saluda Medical Pty, Ltd.
 Evoke SCS System Neurology PMA Supplement Approved (30-day notice) P190002/S048 Jun 12, 2026 28d
Medtronic Neuromodulation
 InterStim® Therapy System Other PMA Supplement Approved (30-day notice) P970004/S453 Jun 12, 2026 28d
Kardium, Inc.
 Globe® Catheter; Globe® Pulsed Field System Cardiovascular PMA Supplement Approved (30-day notice) P240044/S005 Jun 12, 2026 25d
Medtronic Minimed
 Simplera system Diagnostics PMA Supplement Approved P160007/S060 Jun 12, 2026 133d
Medtronic Neuromodulation
 InterStim® Therapy System Other PMA Supplement Approved (30-day notice) P080025/S348 Jun 12, 2026 28d
Croma-Pharma GmbH
 saypha® ChiQ™ Surgical PMA Approved P250021 Jun 12, 2026 351d
Source: U.S. FDA via openFDA. 1701 decisions dated Apr 26, 2026 – Aug 24, 2026. Every row links to its FDA record. Last refreshed 2026-08-24 08:00. FDA publishes decided submissions only; pending reviews are not public data.
Showing the 900 most recent of 1,701 records. The complete set is published at data/submissions.json.