Latest 510(k) clearances
Newest first, 50 per page. Open a clearance to see any recalls that name it.
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup Osteoremedies, LLC | KWL |
| Jul 24, 2026 | K262165 | FARADRIVE Steerable Sheath (M004PF21M402) Boston Scientific Corporation | DRA |
| Jul 24, 2026 | K262152 | VS-370CF, VS-370CT VISION MEDICAL Co., Ltd., KR | FCX |
| Jul 24, 2026 | K262121 | Ion-L Navigated Instruments SurGenTec, LLC | OLO |
| Jul 24, 2026 | K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) Luma Vision Limited, IE | OBJ |
| Jul 24, 2026 | K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 Thermo Fisher Scientific (Oxoid Ltd.), GB | JTN |
| Jul 24, 2026 | K261488 | OBSIDIO Conformable Embolic Boston Scientific Corporation | KRD |
| Jul 24, 2026 | K261364 | Atellica CH Acetaminophen 2 (ACTM) Siemens Healthcare Diagnostics, Inc. | LDP |
| Jul 24, 2026 | K261349 | SwiftMR Airs Medical, Inc., KR | QIH |
| Jul 24, 2026 | K261312 | Temporary Keratoprosthesis (QuickSet TKP) Eyekon Medical, Inc. | MLP |
| Jul 24, 2026 | K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasou Cook Ireland, Ltd., IE | KTI |
| Jul 24, 2026 | K261267 | Careflux H60;Careflux H70;Careflux V500 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jul 24, 2026 | K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America | GEX |
| Jul 24, 2026 | K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellan Hycor Biomedical | DHB |
| Jul 24, 2026 | K261024 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Jul 24, 2026 | K261014 | Accuro® 3S Needle Guide Kit Rivanna Medical, Inc. | ITX |
| Jul 24, 2026 | K260948 | Air Compression Massager (EP30B001 I) Wavepulse (Xiamen) Healthcare Technology Co., Ltd., CN | IRP |
| Jul 24, 2026 | K260598 | 5 Wavelength LED Facemask (TN2508) iSMART Developments, Ltd., GB | OHS |
| Jul 24, 2026 | K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) MANTIZ Co., Ltd., KR | NKB |
| Jul 24, 2026 | K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) Shenzhen TPH Technology Co., Ltd., CN | HGX |
| Jul 24, 2026 | K260192 | DIANA ROPCA ApS, DK | QIH |
| Jul 24, 2026 | K254180 | PerfusiX-Imaging LIMIS Development B.V., NL | OWN |
| Jul 24, 2026 | K253943 | Tiger 2 System Zavation Medical Products, LLC | NKB |
| Jul 24, 2026 | K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection Deka R&D Corp | FRN |
| Jul 24, 2026 | K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Devic Medical Impact, KR | GCJ |
| Jul 24, 2026 | K253452 | Accuro 3S Rivanna Medical, Inc. | IYO |
| Jul 24, 2026 | K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P Ge Medical Systems Information Technologies, Inc. | MHX |
| Jul 24, 2026 | K252370 | GEN 4 JOY Wheelchair Free Wheelchair Mission | IOR |
| Jul 23, 2026 | K262143 | ImageGrid StreamVue Candelis, Inc. | LLZ |
| Jul 23, 2026 | K262116 | TRUE METRIX Self Monitoring Blood Glucose System Trividia Health, Inc. | NBW |
| Jul 23, 2026 | K261853 | Gepotidacin GEP 10 µg Liofilchem, Inc. | JTN |
| Jul 23, 2026 | K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) Hefei Meyer Optoelectronic Technology, Inc., CN | OAS |
| Jul 23, 2026 | K261734 | Klassic Infection Spacer System Total Joint Orthopedics, Inc. | JWH |
| Jul 23, 2026 | K261694 | CORE 300 Digital Stethoscope Eko Health, Inc. | DQD |
| Jul 23, 2026 | K261644 | Perfadex Plus Xvivo Perfusion AB, SE | KDN |
| Jul 23, 2026 | K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagn Esonic Technology (Wuhan) Co., Ltd., CN | IYN |
| Jul 23, 2026 | K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) Guangzhou Daxin Health Technology Co., Ltd., CN | DXN |
| Jul 23, 2026 | K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) Microlife Corporation, CN | DXN |
| Jul 23, 2026 | K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) Beijing Konted Medical Technology Co.,Ltd, CN | IYN |
| Jul 23, 2026 | K254096 | VELMENI for DENTISTS (V4D) 3D Velmeni, Inc. | QIH |
| Jul 23, 2026 | K253932 | FACEGYM Pro Device (HD-109) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | NFO |
| Jul 23, 2026 | K253044 | RXiBreeze PAP System (RXiBreeze 20C) Resvent Medical Technology Co., Ltd., CN | BZD |
| Jul 23, 2026 | K253041 | 3d Cage Cervical Fims Co., Ltd., KR | ODP |
| Jul 23, 2026 | K251576 | Total Flow Medical Femoral Arterial (TFA) cannula Total Flow Medical Limited, CA | SFF |
| Jul 22, 2026 | K262211 | Lancet Tianjin Huahong Technology Co., Ltd., CN | QRL |
| Jul 22, 2026 | K262094 | E3D-C Interbody System Evolution Spine | OVE |
| Jul 22, 2026 | K262086 | PreludeSYNC Radial Compression Device Merit Medical Systems, Inc. | DXC |
| Jul 22, 2026 | K262075 | Lapidus Screw Kit Relja Innovations, LLC | HWC |
| Jul 22, 2026 | K261179 | AlphaTriPart - Monopolar MIC Instruments Gimmi GmbH, DE | GEI |
| Jul 22, 2026 | K261113 | Op.n Spine Navigation and Robotic Guidance Ecential Robotics, FR | OLO |