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 |
|---|---|---|---|
| Oct 20, 2026 | K262093 | Accuro XV Rivanna Medical, Inc. | IYO |
| Oct 20, 2026 | K262062 | CINA-Aneurysm Avicenna.Ai, FR | QBS |
| Oct 20, 2026 | K260708 | Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital F Vein 360 | FGB |
| Oct 20, 2026 | K260215 | BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) Bd Biosciences | OYE |
| Oct 20, 2026 | DEN260027 | Elecsys HBsAg II quant II RxDx Roche Diagnostics | SJM |
| Oct 19, 2026 | K262932 | AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) Shenzhen Accompany Technology Co., Ltd., CN | OHS |
| Oct 19, 2026 | K262917 | Reprocessed BRK Transseptal Needle Innovative Health, LLC | NMK |
| Oct 19, 2026 | K262147 | CINA-Aneurysm+ Avicenna.Ai, FR | QIH |
| Oct 19, 2026 | K261203 | multiFiltratePRO System Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Oct 19, 2026 | K261189 | Freedom Nail Ankle Fusion System McGinley Orthopaedic Innovations | HSB |
| Oct 19, 2026 | K261109 | Access MeMed BV Beckman Coulter, Inc. | QPS |
| Oct 19, 2026 | K260510 | VenusCT Linatech, LLC | SFV |
| Oct 19, 2026 | K260403 | 7D Surgical System (10-0001) 7D Surgical ULC, CA | OLO |
| Oct 18, 2026 | K262000 | Sway System (Sports Plus) Sway Medical, Inc. | POM |
| Oct 16, 2026 | K263267 | Endox Test Strips Ibt Scientific | JOJ |
| Oct 16, 2026 | K263266 | Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set Route 92 Medical, Inc. | NRY |
| Oct 16, 2026 | K263254 | Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) Xiamen Compower Medical Tech. Co., Ltd., CN | BTM |
| Oct 16, 2026 | K263234 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Oct 16, 2026 | K262941 | Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens Bausch + Lomb, Inc. | LPL |
| Oct 16, 2026 | K262523 | Amber Arte Hass Corp., KR | EIH |
| Oct 16, 2026 | K262478 | BCS Bioceramic Sealer BCS Device Pte., Ltd., SG | KIF |
| Oct 16, 2026 | K262443 | Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) Sofradim Production, FR | OWT |
| Oct 16, 2026 | K262284 | KIM BLUE Desarrollo e Investigación Médica Aragonesa S.L., ES | OTN |
| Oct 16, 2026 | K261782 | MODO DUO Electric Pump (B11621, B11673) Tomy International, Inc. | HGX |
| Oct 16, 2026 | K261585 | Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Oct 16, 2026 | K261574 | Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) Hong Qiangxing (Shenzhen) Electronics Limited, CN | NUH |
| Oct 16, 2026 | K261245 | Restrata Acera Surgical, Inc. | QSZ |
| Oct 16, 2026 | K260801 | Sensinel Cardiopulmonary Management (CPM) System Analog Devices | MWI |
| Oct 16, 2026 | K260605 | Lilium one (USM330) Lilium Otsuka Co., Ltd., JP | IYO |
| Oct 16, 2026 | K260391 | AVIEW Aorta Metrics Coreline Soft Co., Ltd., KR | JAK |
| Oct 16, 2026 | K260315 | cCeLL - In vivo VPIX Medical, Inc., KR | GWG |
| Oct 16, 2026 | K260180 | Carecube Negative Pressure Isolation Chamber (1BY) Carecubes, Inc. | LGM |
| Oct 16, 2026 | K260168 | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) Skycade Med Corporation | DQX |
| Oct 16, 2026 | K254094 | Endox High Level Disinfectant Whiteley USA, Inc. | MED |
| Oct 16, 2026 | K252344 | BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) Becton, Dickinson and Company | JKA |
| Oct 15, 2026 | K263269 | Park's Pectus System Tdm Co., Ltd., KR | HRS |
| Oct 15, 2026 | K262904 | INDIGO® Aspiration System Penumbra, Inc. | QEW |
| Oct 15, 2026 | K262674 | Giranel Guiding Sheath Set Kossel Medtech (Suzhou) Co., Ltd., CN | DYB |
| Oct 15, 2026 | K262576 | twiist Loop Algorithm Deka Research and Development Corp. | QJI |
| Oct 15, 2026 | K262522 | Odys-SI Screw Medyssey Co, Ltd., KR | OUR |
| Oct 15, 2026 | K262447 | The Circadia CX00 System (CX00) Circadia Health, Inc. | DRT |
| Oct 15, 2026 | K262214 | Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) Guangzhou Aimooe Technology Co., Ltd., CN | HAW |
| Oct 15, 2026 | K262097 | MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) Carl Zeiss Meditec Cataract Technologies | HQC |
| Oct 15, 2026 | K261616 | Single-Use EBUS Balloon Micro-Tech (Nanjing) Co., Ltd., CN | PSV |
| Oct 15, 2026 | K261361 | TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORU Carl Zeiss Meditec, AG, DE | LFL |
| Oct 15, 2026 | K260827 | Oncomine Dx Express Test Life Technologies Corporation | SBY |
| Oct 15, 2026 | K260530 | epi-ConneKt Wound Matrix MLM Biologics, Inc. | KGN |
| Oct 14, 2026 | K263208 | Vantage Lumbar Decompression Kit SurGenTec, LLC | HRX |
| Oct 14, 2026 | K262885 | 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) Guangxi Hope Medical Devices Technology Co., Ltd., CN | FTC |
| Oct 14, 2026 | K262455 | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld C Intuitive Surgical, Inc. | GCJ |