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 16, 2026 | K261896 | iOS CamAPS FX CamDiab, GB | QJI |
| Sep 16, 2026 | K261888 | ClearClub Impression Material ClearClub | SHI |
| Sep 16, 2026 | K261865 | AerFrame Alignment Laser Box (LBV2) Stabilix, LLC | IYE |
| Sep 16, 2026 | K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter OrbusNeich Medical (Shenzhen) Co., Ltd., CN | PNO |
| Sep 16, 2026 | K261758 | Embrace Vision Neonatal MRI System Aspect Imaging, Ltd., IL | LNH |
| Sep 16, 2026 | K261712 | Ceribell EEG Analysis Software Ceribell, Inc. | OLT |
| Sep 16, 2026 | K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH |
| Sep 16, 2026 | K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) Gt Metabolic Solutions, Inc. | SAH |
| Sep 16, 2026 | K261400 | Ambu® aScope Gastro; Ambu® aScope Gastro Large Ambu A/S, DK | FDS |
| Sep 16, 2026 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) Guangdong Newdermo Biotech Co., Ltd., CN | NFO |
| Sep 16, 2026 | K261283 | APERTO Lucent MRI System Fujifilm Corporation, JP | LNH |
| Sep 16, 2026 | K260906 | a2z-Abdo-Triage A2z Radiology Ai, Inc. | QAS |
| Sep 16, 2026 | K260309 | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set Ambu A/S, DK | EOQ |
| Sep 16, 2026 | K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) Amptron Medical, Inc. | BZK |
| Sep 16, 2026 | K260220 | Route 92 Medical Full Length 046 Access System Route 92 Medical, Inc. | QJP |
| Sep 16, 2026 | K254212 | NC PTA Balloon Dilatation Catheter Kossel Medtech (Suzhou) Co., Ltd., CN | LIT |
| Sep 16, 2026 | K254181 | Aristotle 65 Macrowire Scientia Vascular | MOF |
| Sep 16, 2026 | K254152 | Dia-X Sil Light Body DiaDent Group International, KR | ELW |
| Sep 16, 2026 | K254142 | Dia-X Sil Heavy Body DiaDent Group International, KR | ELW |
| Sep 15, 2026 | K262963 | TMC Implant Fixation System Treace Medical Concepts, Inc. | HRS |
| Sep 15, 2026 | K262057 | GMK Extension Medacta International SA, CH | JWH |
| Sep 15, 2026 | K261861 | SPINEsim v1.0 Mdsim S.A., LU | LLZ |
| Sep 15, 2026 | K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 Aramis Global AI Consultancies, LLC, AE | QIH |
| Sep 15, 2026 | K261447 | CVAC® Aspiration System Calyxo, Inc. | FGB |
| Sep 15, 2026 | K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated Covidien, LLC | GEI |
| Sep 15, 2026 | K260446 | Tontarra Punches and Rongeurs Tontarra Medizintechnik GmbH, DE | HAE |
| Sep 15, 2026 | K260145 | YJ-K1K2 Wheelchair (YJ-013F) Zhenjiang Assure Medical Equipment Co., Ltd., CN | IOR |
| Sep 15, 2026 | K260144 | Reclining wheelchair (YJ-013L) Zhenjiang Assure Medical Equipment Co., Ltd., CN | IOR |
| Sep 15, 2026 | K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) Zhenjiang Assure Medical Equipment Co., Ltd., CN | IOR |
| Sep 15, 2026 | K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° Karl Storz SE & CO. KG, DE | EOB |
| Sep 15, 2026 | K254214 | OOOPDS Taiwan Main Orthopaedic Biotechnology Co., Ltd., TW | LLZ |
| Sep 14, 2026 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTI Xenix Medical | NKB |
| Sep 14, 2026 | K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth Becton Dickinson and Company | JTZ |
| Sep 14, 2026 | K261517 | qCT Lung (v1.0) Qure.Ai Technologies Pvt. , Ltd., IN | QDQ |
| Sep 14, 2026 | K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) Eurosets S.R.L, IT | DTZ |
| Sep 14, 2026 | K261089 | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit Maduro Medical, Inc. | NRY |
| Sep 14, 2026 | K260795 | Hand-held Dental X-ray System (HyperLight-M) Changzhou Sifary Medical Technology Co., Ltd., CN | EHD |
| Sep 14, 2026 | K260781 | Yumizen H550 HORIBA ABX SAS, FR | GKZ |
| Sep 14, 2026 | K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) Ovesco Endoscopy AG, DE | PKL |
| Sep 13, 2026 | K262526 | Safety lancet (XL) Tianjin Huahong Technology Co., Ltd., CN | FMK |
| Sep 12, 2026 | K261287 | Digistat Care Ascom Ums Srl Unipersonale, IT | MSX |
| Sep 12, 2026 | K260133 | CADDIE Odin Medical Limited, GB | QNP |
| Sep 11, 2026 | K262874 | CraniUS Plate CraniUS, LLC | GWO |
| Sep 11, 2026 | K262861 | PureLift Pro Max Xtreem Pulse, LLC | NFO |
| Sep 11, 2026 | K262763 | iLet Dosing Decision Software Beta Bionics, Inc. | QJI |
| Sep 11, 2026 | K262397 | CuratOR EX2742 Eizo Corporation, JP | GCJ |
| Sep 11, 2026 | K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETE Bone Solutions, Inc. | MQV |
| Sep 11, 2026 | K262151 | SpaceOAR Flex System Boston Scientific Corporation | OVB |
| Sep 11, 2026 | K262050 | Vioseal X Spident Co., Ltd., KR | KIF |
| Sep 11, 2026 | K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF Sy INNO Holdings Inc. DBA Innovasis | OVD |