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 11, 2026 | K262007 | PRIMED AAMI Level 3 Open Back Gowns PRIMED Medical Products, Inc., CA | QPC |
| Sep 11, 2026 | K261837 | FINDER Flu A&B/SARS-CoV-2 Test Baebies, Inc. | QOF |
| Sep 11, 2026 | K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) Bio Compression Systems, Inc. | JOW |
| Sep 11, 2026 | K261580 | ZBPro Diagnostic (Version 2.0) Zbeats, Inc. | MLO |
| Sep 11, 2026 | K261338 | RENASYS DYNAFLOW Kit (66807741) Smith & Nephew Medical, Ltd., GB | OMP |
| Sep 11, 2026 | K261305 | MICSI-PET Microstructure Imaging, Inc. | KPS |
| Sep 11, 2026 | K261255 | KOWA FM-600 Kowa Company, Ltd. Chofu Factory, JP | MYC |
| Sep 11, 2026 | K261019 | ANTERION Heidelberg Engineering GmbH, DE | OBO |
| Sep 11, 2026 | K260410 | Single Use Ureteral Access Sheath Zhejiang Chuangxiang Medical Technology Co., Ltd., CN | FED |
| Sep 11, 2026 | K260115 | DRIM-Nail System 41Medical AG, CH | |
| Sep 11, 2026 | K260063 | GSPE Spacer The General Hospital Corporation, d/b/a Massachusetts | JWH |
| Sep 11, 2026 | K260001 | Mint ACE Pump Beta Bionics, Inc. | QFG |
| Sep 11, 2026 | K254185 | Potenza Prime Jeisys Medical Incorporated, KR | GEI |
| Sep 11, 2026 | K254177 | Disposable Sterile Skull Drill (LZ) Guizhou Zirui Technology Co., Ltd., CN | HBF |
| Sep 11, 2026 | K254174 | Surgical Power System Guizhou Zirui Technology Co., Ltd., CN | HBC |
| Sep 11, 2026 | K254123 | Ecomed Disposable Administration Sets Ecomed Solutions, LLC | FPA |
| Sep 11, 2026 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Shenzhen Xinyan Medical Technology Co.,ltd., CN | MWJ |
| Sep 11, 2026 | K254072 | BoneVue Curvebeam AI / Curvebeam, LLC | KGI |
| Sep 11, 2026 | K254051 | Extroducer Infusion Catheter System SmartWise Sweden AB, SE | KRA |
| Sep 11, 2026 | K254041 | SkinSmart Antimicrobial HydroGel Magic Science Supply, LLC | FRO |
| Sep 11, 2026 | K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (5 Vitaltec Corporation, TW | BTO |
| Sep 10, 2026 | K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) Wuhan Pioon Technology Co., Ltd., CN | GEX |
| Sep 10, 2026 | K262293 | EVOLUTION MPX Total Knee System Suzhou Microport Orthorecon Co., Ltd., CN | JWH |
| Sep 10, 2026 | K262202 | Cerasmart Forte GC America, Inc. | EBF |
| Sep 10, 2026 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB Olympus Medical Systems Corp., JP | FET |
| Sep 10, 2026 | K261929 | Upper Arm Blood pressure monitor (BP7155D) OMRON Healthcare, Inc. | DXN |
| Sep 10, 2026 | K261795 | Quicktome Software Suite Omniscient Neurotechnology Pty, Ltd., AU | QIH |
| Sep 10, 2026 | K261696 | ACUNAV Luxera 4D ICE Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| Sep 10, 2026 | K261562 | Diode Laser Therapy System Sanhe LEFIS Electronics Co., Ltd., CN | GEX |
| Sep 10, 2026 | K261409 | BioTeke® Multi-Drug Urine Test Cup Bioteke Corporation (Wuxi) Co., Ltd., CN | NFT |
| Sep 10, 2026 | K260879 | 4DM INVIA, LLC | QIH |
| Sep 10, 2026 | K260110 | danumed Extension Set for Gastrostomy Button Danumed Medizintechnik GmbH, DE | PIF |
| Sep 10, 2026 | K254246 | LT Antibacterial Foam with Silver Dressing Zhejiang Longterm Medical Technology Co., Ltd., CN | NAD |
| Sep 10, 2026 | K254111 | Irrigation/Urology Sets B.Braun Medical, Inc. | LJH |
| Sep 10, 2026 | K254074 | TruPress Procerus Enterprises | DRS |
| Sep 10, 2026 | K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) Lakong Medical Devices Co., Ltd., CN | SJH |
| Sep 10, 2026 | K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) Koh Young Technology, Inc., KR | HAW |
| Sep 9, 2026 | K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Top Glove Sdn. Bhd., MY | LZA |
| Sep 9, 2026 | K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) Guangzhou Red Pine Medical Instrument Co., Ltd., CN | FGB |
| Sep 9, 2026 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color Maxter Healthcare, Inc. | LZA |
| Sep 9, 2026 | K261470 | QF10 E.A.M Benelux B.V, NL | NHV |
| Sep 9, 2026 | K260997 | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) Endoclot Plus Co., Ltd., CN | PLL |
| Sep 9, 2026 | K260652 | ColActive Plus Covalon Technologies, Ltd., CA | KGN |
| Sep 9, 2026 | K252486 | ChestView US (1.1) Gleamer, FR | MYN |
| Sep 9, 2026 | K251417 | ReVISION 2 Argus Cognitive, Inc. | QIH |
| Sep 8, 2026 | K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions B-One Ortho, Corp. | JWH |
| Sep 8, 2026 | K262173 | N22 Offset Humeral Head Shoulder Innovations, Inc. | KWT |
| Sep 8, 2026 | K261987 | Reusable SmartPeg Osstell AB, SE | EKX |
| Sep 8, 2026 | K261956 | Dental Barriers and Sleeves (AB0006) ANI Co., Ltd., KR | PEM |
| Sep 8, 2026 | K261823 | da Vinci Surgical System, Model IS5000 Intuitive Surgical, Inc. | NAY |