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 |
|---|---|---|---|
| Jul 22, 2026 | K260964 | NanoZoomer S540MD Slide Scanner System Hamamatsu Photonics K.K., JP | PSY |
| Jul 22, 2026 | K260804 | Anovo Surgical System (6Ne) Momentis Surgical , Ltd., IL | SCV |
| Jul 22, 2026 | K260721 | Tornier Perform Advanced Glenoid Tornier, Inc. | KWS |
| Jul 22, 2026 | K254296 | Ossiclear (Ossiclear System) Sounduct, FR | LXB |
| Jul 22, 2026 | K253840 | STEDI Scan Device Stroke DX | QAF |
| Jul 21, 2026 | K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves O&M Halyard, Inc. | LZA |
| Jul 21, 2026 | K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) Xuzhou Kernel Medical Equipment Co., Ltd., CN | |
| Jul 21, 2026 | K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) Rhein Laser Technologies Co., Ltd., CN | GEX |
| Jul 21, 2026 | K261728 | One-Fil LC Mediclus Co., Ltd., KR | EJK |
| Jul 21, 2026 | K261406 | Versalock Proximal Tibial Plating System GM Dos Reis Industria e Comercio Ltda., BR | HRS |
| Jul 21, 2026 | K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus c Hycor Biomedical | DHB |
| Jul 21, 2026 | K260500 | ResolutionMD ResolutionMD, Inc., CA | LLZ |
| Jul 21, 2026 | K253814 | Raney Clips Kit Beijing Honghugaoxiang Science and Technology Development CO, CN | HBO |
| Jul 21, 2026 | K253770 | CardIQ Suite GE Medical Systems SCS, FR | JAK |
| Jul 21, 2026 | DEN250068 | OTTAVA Robotic Surgical System Auris Health, Inc., part of Johnson & Johnson MedTech | SIR |
| Jul 20, 2026 | K261632 | Thunderbolt System Responsive Arthroscopy, Inc. | MBI |
| Jul 20, 2026 | K261573 | ENDOSCOPE HOLDER (182214) Aktormed GmbH, DE | QZB |
| Jul 20, 2026 | K261535 | Hi-D Imaging 4TAVR Hi-D Imaging AG, CH | QIH |
| Jul 20, 2026 | K261011 | Sleep Apnea Feature (v2.0) Samsung Electronics Co., Ltd., KR | QZW |
| Jul 20, 2026 | K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) MacroLux Medical Technology Co., Ltd., CN | FGB |
| Jul 20, 2026 | K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examinati Hartalega NGC Sdn. Bhd., MY | LZA |
| Jul 20, 2026 | K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips Taiwan Surgical Corporation, TW | FZP |
| Jul 17, 2026 | K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical C Stryker Spine | ODP |
| Jul 17, 2026 | K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup Assure Tech., LLC | NFT |
| Jul 17, 2026 | K261693 | Diode laser hair removal machine (QDTM-04) Beijing Nubway S&T Co., Ltd., CN | GEX |
| Jul 17, 2026 | K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) Shenzhen Chuanghong Zhilian Technology Co., Ltd., CN | OAP |
| Jul 17, 2026 | K261658 | LoFric Origo Pro Coudé Wellspect AB, SE | EZD |
| Jul 17, 2026 | K261614 | LED LCD Monitor (OEV-271H) Lg Electronics.Inc, KR | GCJ |
| Jul 17, 2026 | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit Biofire Defense, LLC | PMN |
| Jul 17, 2026 | K261046 | Dental Zirconia Blank & Coloring Liquid Hunan Qinghao Puzhong Technology Co., Ltd., CN | EIH |
| Jul 17, 2026 | K260694 | ZEISS CLINIC 360 Carl Zeiss Meditec, AG, DE | NFJ |
| Jul 17, 2026 | K254006 | Drivewire 35 Guidewire Rapid Medical Ltd., IL | MOF |
| Jul 17, 2026 | K253963 | Cubresa BrainPET Cubresa, Inc., CA | OUO |
| Jul 17, 2026 | K253694 | Natural Cycles Natural Cycles Nordic AB, SE | PYT |
| Jul 17, 2026 | K253011 | Catalyft PL Expandable Interbody System Medtronic Sofamor Danek USA, Inc. | MAX |
| Jul 17, 2026 | K251952 | Virasight Virasoft Corporation | PSY |
| Jul 17, 2026 | DEN250040 | SportSuite Vision Software Stryker Endoscopy | SIT |
| Jul 16, 2026 | K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spannin TriMed, Inc. | HRS |
| Jul 16, 2026 | K261706 | Endomat Select (UP220) KARL STORZ SE & CO. KG, DE | HIG |
| Jul 16, 2026 | K261674 | Skin Air Cooling System (QALF-01) Beijing Nubway S&T Co., Ltd., CN | GEX |
| Jul 16, 2026 | K261309 | Palisades Buttress Plate System Bethesda Medical Devices, LLC | KWQ |
| Jul 16, 2026 | K261271 | Cable-Ready® Cable Grip System Pioneer Surgical Technology, Inc. | JDQ |
| Jul 16, 2026 | K260021 | cobas® BV/CV Roche Molecular Systems, Inc. | PQA |
| Jul 16, 2026 | K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) Scientia Vascular, Inc. | NRY |
| Jul 15, 2026 | K262030 | Aventus Thrombectomy System Inquis Medical | QEZ |
| Jul 15, 2026 | K262006 | EnSite X EP System Abbott Medical | DQK |
| Jul 15, 2026 | K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457 Dongguan Miqiang Technology Co., Ltd., CN | OHS |
| Jul 15, 2026 | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System Kyocera Medical Technologies, Inc. | OVD |
| Jul 15, 2026 | K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 Better Diagnostics AI Corp. | MYN |
| Jul 15, 2026 | K260739 | Profoject Pen Needles (Model A; Model B) CMT Health PTE., Ltd., SG | FMI |