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 |
|---|---|---|---|
| Aug 27, 2026 | K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) Zhengzhou PZ Laser Slim Technology Co., Ltd., CN | GEX |
| Aug 27, 2026 | K261802 | Glidewell Denture Base Resin Prismatik Dentalcraft, Inc. | EBI |
| Aug 27, 2026 | K261360 | EasyCare Tx 2 Resmed Corp | MOD |
| Aug 27, 2026 | K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) Gebauer Company | MLY |
| Aug 27, 2026 | K260856 | Disposable Distal Attachment D-201-13404 Olympus Medical Systems Corporation, JP | FDS |
| Aug 27, 2026 | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 Olympus Medical Systems Corporation, JP | FDS |
| Aug 27, 2026 | K260751 | 35 Helix Guidewire Piraeus Medical, Inc. | MOF |
| Aug 27, 2026 | K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matr Berkeley Advanced Biomaterials | KGN |
| Aug 27, 2026 | K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ON Ascensia Diabetes Care | NBW |
| Aug 27, 2026 | K260481 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Aug 27, 2026 | K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) Olympus Medical Systems Corporation, JP | PSV |
| Aug 27, 2026 | K253859 | Scarlet Pro (Scarlet Pro) VIOL Co., Ltd., KR | GEI |
| Aug 26, 2026 | K262595 | VariLift-C Cervical Interbody Fusion System Wenzel Spine, Inc. | ODP |
| Aug 26, 2026 | K262581 | GraftGun Universal Graft Delivery System (GDS®) SurGenTec, LLC | FMF |
| Aug 26, 2026 | K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DB JOYTECH Healthcare Co., Ltd., CN | DXN |
| Aug 26, 2026 | K261153 | LithoVue Elite Digital Flexible Ureteroscope System Boston Scientific Corporation | FGB |
| Aug 26, 2026 | K261142 | Ponto 5 Mini; Ponto 5 Superpower Oticon Medical AB, SE | MAH |
| Aug 26, 2026 | K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor Sony Corporation, JP | GCJ |
| Aug 26, 2026 | K260811 | Heartvue.Proton Heartvue.ai, Inc. | QIH |
| Aug 26, 2026 | K260733 | MRIA Radiation Therapy Information System (MRIA) Manteia Technologies Co., Ltd., CN | IYE |
| Aug 26, 2026 | K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMM Principle & Will Co., Ltd., WS | FYA |
| Aug 26, 2026 | K254103 | HOPKINS Telescopes for Arthroscopy Karl Storz SE & CO. KG, DE | HRX |
| Aug 26, 2026 | K253877 | StimTrial Neuromodulation System Bioventus, LLC | GZF |
| Aug 26, 2026 | K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Ed Maquet Critical Care AB, SE | PIF |
| Aug 25, 2026 | K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) SteriLance Medical (Suzhou), Inc., CN | QRK |
| Aug 25, 2026 | K261747 | Report Studio Beacon Biosignals, Inc. | OLV |
| Aug 25, 2026 | K261719 | Promisemed X-Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Aug 25, 2026 | K261595 | Ceevra Reveal 4 Ceevra, Inc. | QIH |
| Aug 25, 2026 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) Guilin Kevin Peter Technology Co., Ltd., CN | KIF |
| Aug 25, 2026 | K254304 | iNOS intraoral biosensor Achaemenid, LLC | PLC |
| Aug 25, 2026 | K253879 | MONOFIX PDO Samyang Holdings Corporation, KR | NEW |
| Aug 25, 2026 | K252535 | Inno-Switch Laparoscopic Instruments Taiwan Surgical Corporation, TW | GEI |
| Aug 25, 2026 | K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray Sol-Millennium Medical, Inc. | FMF |
| Aug 25, 2026 | DEN250049 | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System Abbott Diabetes Care | SJD |
| Aug 24, 2026 | K261381 | TiLink-L SI Joint Fusion System SurGenTec, LLC | OUR |
| Aug 24, 2026 | K260604 | BiWaze Clear System Abmrc, LLC | NHJ |
| Aug 24, 2026 | K260246 | SEISMIQ Intravascular Lithotripsy System Bolt Medical, Inc. | PPN |
| Aug 24, 2026 | K260106 | OsteoCoil GT Active Compression System Flower Orthopedics Corporation DBA Conventus Flower Orthoped | HWC |
| Aug 24, 2026 | K254286 | Guided Bone Regeneration System DentalMaster(Xiamen)Medical Technology Co., Ltd., CN | DZL |
| Aug 24, 2026 | K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 9 Sonoscape Medical Corp., CN | IYN |
| Aug 24, 2026 | K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments Biomet Orthopedics, Inc. | JDI |
| Aug 23, 2026 | K260691 | BTL-699 BTL Industries, Inc. | OBP |
| Aug 22, 2026 | K253910 | Stitch - Suture Wires and Tapes GM Dos Reis Industria e Comercio Ltda., BR | GAT |
| Aug 21, 2026 | K262538 | Artix MT;Artix Thin-Walled Sheath Inari Medical, Inc. | QEW |
| Aug 21, 2026 | K262127 | DS Core CBCT Anatomy Dentsply Sirona | QIH |
| Aug 21, 2026 | K262089 | Disposable Warming Blanket Hangzhou Tappa Medical Technology Co., Ltd., CN | DWJ |
| Aug 21, 2026 | K262074 | Any-Zircos Mediclus Co., Ltd., KR | EIH |
| Aug 21, 2026 | K262005 | Affera Integrated Mapping System Medtronic, Inc. | DQK |
| Aug 21, 2026 | K261882 | Pisces-SC Standalone Cervical Interbody System Osseus Fusions Systems, LLC | OVE |
| Aug 21, 2026 | K261710 | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors Apyx Medical Corporation | QPB |