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 25, 2026 | K254230 | CapsoView (CVV); CapsoCloud (CLD) CapsoVision, Inc. | QZF |
| Sep 25, 2026 | K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) Hyundai Bioland Co., Ltd., KR | NPM |
| Sep 25, 2026 | K254058 | DistaSense(TM) (v1) Life Detection Technologies | DRT |
| Sep 24, 2026 | K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress inomed Medizintechnik GmbH, DE | GWF |
| Sep 24, 2026 | K262955 | OsseoFit Stemless Shoulder System Zimmer, Inc. | PKC |
| Sep 24, 2026 | K262618 | Arthrex Spine Compression FT Screw Arthrex, Inc. | MRW |
| Sep 24, 2026 | K262252 | MPa Max adhesive Den-Mat Holdings, LLC | KLE |
| Sep 24, 2026 | K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) Shenzhen Nuon Medical Equipment Co., Ltd., CN | OAP |
| Sep 24, 2026 | K262168 | QIAstat-Dx BCID GN Plus AMR Panel QIAGEN GmbH, DE | PEN |
| Sep 24, 2026 | K262149 | corra® cervical plating system Carlsmed, Inc. | KWQ |
| Sep 24, 2026 | K261345 | Pediatric Nailing Platform Femur OrthoPediatrics Corp. | HSB |
| Sep 24, 2026 | K261078 | Electric Scooter (FNS01,FNS03) Anhui Jbh Medical Apparatus Co., Ltd., CN | INI |
| Sep 24, 2026 | K260949 | Disposable Belts for Polysomnography (CNSAC) CNSAC Medshop GmbH, DE | MNR |
| Sep 24, 2026 | K260313 | MD-6000S Bladder Scanner MEDA Co., Ltd., CN | IYO |
| Sep 24, 2026 | K260214 | STA® - Liquid Anti-Xa Diagnostica Stago, Inc. | KFF |
| Sep 24, 2026 | K260114 | Align® Cover and Pad Guidance Tool CIVCO Medical Instruments Co., Inc. | ITX |
| Sep 24, 2026 | K254303 | KARL STORZ SUPRALOOP Karl Storz SE & CO. KG | KNF |
| Sep 24, 2026 | K254199 | PicoreMax (PicoreMax) BLUECORE COMPANY Co., Ltd., KR | GEX |
| Sep 23, 2026 | K263049 | SABER-C System Elevation Spine | OVE |
| Sep 23, 2026 | K262582 | Electric wheelchair (GP100) Suzhou Green Pine Medical Co., Ltd., CN | ITI |
| Sep 23, 2026 | K262353 | BTL-299-F BTL Industries, Inc. | KPI |
| Sep 23, 2026 | K262254 | Hair Growth Comb (X-GC01) Guangdong Ashmore Health Technology Co., Ltd., CN | OAP |
| Sep 23, 2026 | K262207 | Cemented Plus Abutment Unidental Co., Ltd., KR | NHA |
| Sep 23, 2026 | K262156 | Anti-HCV Next Abbott Laboratories | MZO |
| Sep 23, 2026 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece SETAGAYA SEIKI Co., Ltd., JP | EFB |
| Sep 23, 2026 | K262067 | iFuse Granite Onyx Implant System SI-BONE, Inc. | NKB |
| Sep 23, 2026 | K261892 | ProRib Fixation System Costa Surgical, Inc. | HRS |
| Sep 23, 2026 | K261874 | Syneris PACS v.1.0.1.0 Syneris, CA | LLZ |
| Sep 23, 2026 | K261637 | Single-use Flexible Bronchoscope Hunan Vathin Medical Instrument Co., Ltd., CN | EOQ |
| Sep 23, 2026 | K261453 | G7® Acetabular System Zimmer Biomet | LPH |
| Sep 23, 2026 | K261418 | Liquick X-treme, Liquick X-treme Plus Teleflex Medical, IE | EZD |
| Sep 23, 2026 | K260995 | DynaNail Helix® Fixation System MedShape, Inc. | HWC |
| Sep 23, 2026 | K260597 | VIRTUE QA ProNova Solutions | LHN |
| Sep 23, 2026 | K260117 | Everslide Special Situations, LLC | NUC |
| Sep 23, 2026 | K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) Oxytek Medical Technology Co., Ltd., CN | CAW |
| Sep 22, 2026 | K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics | QOF |
| Sep 22, 2026 | K262442 | HipStudio Analysis Replasia BV, BE | LLZ |
| Sep 22, 2026 | K262390 | BoneXpert Visiana, DK | QIH |
| Sep 22, 2026 | K262299 | Instant-View® hCG Combo II Cassette Test Alfa Scientific Designs, Inc. | JHI |
| Sep 22, 2026 | K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) Samsung HME America, Inc., dba NeuroLogica Corp. | JAK |
| Sep 22, 2026 | K254240 | Echo-2 Neko Health AB, SE | QOK |
| Sep 22, 2026 | K254168 | Actolind® (06.3637. Actolind® Gel Plus) ACTO GmbH, DE | FRO |
| Sep 22, 2026 | K253762 | ErgoSteel (ES0001/696) Strongback Mobility AG C/O Blueaudit GmbH, CH | IOR |
| Sep 22, 2026 | K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) Bh Group Us, LLC | PBX |
| Sep 21, 2026 | K262982 | Core·it Dual Spident Co., Ltd., KR | EBF |
| Sep 21, 2026 | K262547 | KARL STORZ TIPCAM1 Rubina KALR STORZ SE & Co. KG, DE | OWN |
| Sep 21, 2026 | K262109 | Access NT-proBNP Beckman Coulter, Inc. | NBC |
| Sep 21, 2026 | K262108 | FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male L Shanghai Personage Hygiene Products Co., Ltd., CN | HIS |
| Sep 21, 2026 | K261725 | OtoCompanion (Version 1.0) Ironsides Medical, Inc. | SHL |
| Sep 21, 2026 | K261368 | Rapid Platform (R6.7) Ischemaview, Inc. | QIH |