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 |
|---|---|---|---|
| Sep 21, 2026 | K260940 | BellaTek Bars ZimVie US Corp, LLC | NHA |
| Sep 21, 2026 | K260512 | Disposable Ureteral Access Sheath Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | FED |
| Sep 21, 2026 | K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter Zylox Medtech Co., Ltd., CN | LIT |
| Sep 21, 2026 | K254280 | F.A.S.T Screw Steps Ortho, FR | HWC |
| Sep 21, 2026 | K253509 | TriSalus TriNav Advance Infusion System Trisalus Life Sciences | KRA |
| Sep 19, 2026 | K261859 | Electric Scooter (FDB08, FDB08A, FDB12) Anhui JBH Medical Apparatus Co., Ltd., CN | INI |
| Sep 19, 2026 | K252723 | Dynamis Pro Family Fotona D.O.O., SI | GEX |
| Sep 19, 2026 | K241973 | SmartIPL_NI System Lumenis Be, Ltd., IL | GEX |
| Sep 18, 2026 | K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System Vantis Vascular, Inc. | DQY |
| Sep 18, 2026 | K262637 | SLIT LAMP SL-D4 (Type: LED) Topcon Corporation, JP | HJO |
| Sep 18, 2026 | K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor Biolinq Incorporated | SFU |
| Sep 18, 2026 | K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) ICU Medical | LGZ |
| Sep 18, 2026 | K262524 | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) ONE BEAUTY Technology Co., Ltd., CN | OHT |
| Sep 18, 2026 | K262262 | Pathfinder Endoscope Overtube Neptune Medical, Inc. | FED |
| Sep 18, 2026 | K262098 | EnHAnce PEEK Bunion System Nvision Biomedical Technologies | HRS |
| Sep 18, 2026 | K261855 | Elucid PlaqueIQ Elucid Bioimaging, Inc. | LLZ |
| Sep 18, 2026 | K261229 | SCENARIA View Phase 6.0 Fujifilm Corporation, JP | JAK |
| Sep 18, 2026 | K261102 | UNIDRIVE Select System Karl Storz SE & CO. KG, DE | HIH |
| Sep 18, 2026 | K261047 | Dental Diode Laser Device (Laser-Pen) Guilin Kevin Peter Technology Co., Ltd., CN | GEX |
| Sep 18, 2026 | K260008 | Deterioration Index Version 2 Epic Systems Corporation | QNL |
| Sep 18, 2026 | K254238 | MINT MONO Sutures Hans Biomed Corporation, KR | NEW |
| Sep 18, 2026 | K254179 | Drainage Catheter Canyon Medical, Inc., CN | FGE |
| Sep 18, 2026 | K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) Shenzhen Mericonn Technology Co., Ltd., CN | CAF |
| Sep 18, 2026 | K254160 | VacHeal Negative Pressure Wound Therapy System VacHeal, LLC | OKO |
| Sep 18, 2026 | K254095 | 25G Huber Needle Martech Medical Products | PTI |
| Sep 18, 2026 | K253419 | Triever Duo Catheter Inari Medical, Inc. | QEW |
| Sep 18, 2026 | K253146 | Hyperdrive 35 Guidewire Rapid-Medical , Ltd., IL | DQX |
| Sep 17, 2026 | K262913 | Protégé EverFlex Self-expanding Peripheral Stent System Medtronic, Inc. | FGE |
| Sep 17, 2026 | K262495 | Miru 1day UpSide (midafilcon A) Menicon Co, Ltd., JP | LPL |
| Sep 17, 2026 | K262091 | FRAXION Spinal Fixation System Ortler Global Tibbi Gerecler Anonim Sirketi, TR | NKB |
| Sep 17, 2026 | K262073 | Hygienic Protective Bite Cover (2207-010-50) Dürr Dental SE, DE | PEM |
| Sep 17, 2026 | K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® Sa Stryker Instruments | GEI |
| Sep 17, 2026 | K261869 | Integrity Retractable Implant Inserter (6000127) Anika Therapeutics, Inc. | MBI |
| Sep 17, 2026 | K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) Zhengzhou PZ Laser Slim Technology Co., Ltd., CN | GEX |
| Sep 17, 2026 | K261729 | EnSite X EP System Abbott Medical | DQK |
| Sep 17, 2026 | K261673 | LED Therapy Device (QLXY-01) Beijing Nubway S&T Co., Ltd., CN | GEX |
| Sep 17, 2026 | K261392 | TriActive Dental Implant System Paragon Implant Mfg., LLC | DZE |
| Sep 17, 2026 | K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur Corin, Ltd., GB | MBH |
| Sep 17, 2026 | K261266 | MOWANA Auto Duo PENTAMASTER MEDIQ SDN BHD, MY | FMI |
| Sep 17, 2026 | K260677 | Vessel Closure Device (VCD177213P) Vcd Medical S.R.L., IT | FZP |
| Sep 17, 2026 | K260173 | M-Vizion Femoral Revision System Extension Medacta International S.A., CH | LZO |
| Sep 17, 2026 | K254260 | The VEGA Cervical Screw System GS Medical Co., Ltd., KR | NKG |
| Sep 17, 2026 | K254203 | Wearable Breast Pump (Model S36) Shenzhen TPH Technology Co., Ltd., CN | HGX |
| Sep 17, 2026 | K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) Ethicon Endo-Surgery, LLC | GEI |
| Sep 17, 2026 | K252995 | Durashield Device Kit SurGenTec, LLC | GZT |
| Sep 16, 2026 | K262877 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America | GEX |
| Sep 16, 2026 | K262559 | Mouth Guard ChangSha ChuangDuoLe E-Commerce Co., Ltd., CN | OBR |
| Sep 16, 2026 | K262054 | Electric Wheelchair Yongkang Joymax Medical Technology Co., Ltd., CN | ITI |
| Sep 16, 2026 | K261919 | Multifunctional wheelchair (YJ-059) Zhenjiang Assure Medical Equipment Co., Ltd., CN | IOR |
| Sep 16, 2026 | K261913 | X°Port Heart Preservation System Traferox Technologies, Inc., CA | MSB |