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 16, 2026 | K260563 | CN-Suite FIND Surgical Sciences Inc. D/B/A FIND Neuro | OLX |
| Aug 14, 2026 | K262639 | BAGUERA® C Cervical Disc Surgical Instruments Spineart SA, CH | QLQ |
| Aug 14, 2026 | K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System Bard Peripheral Vascular, Inc. | KNW |
| Aug 14, 2026 | K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) Scivita Medical Technology Co., Ltd., CN | FGB |
| Aug 14, 2026 | K262452 | AutoContour (RADAC V6) Radformation, Inc. | QKB |
| Aug 14, 2026 | K262449 | AdvaView ADVAHEALTH SOLUTIONS, LLC | LLZ |
| Aug 14, 2026 | K262424 | Willow 12 Guidewire Arbor Endovascular, LLC | MOF |
| Aug 14, 2026 | K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR1004 Cerenovus, Inc. | HCG |
| Aug 14, 2026 | K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® Boehringer Laboratories, LLC | KNT |
| Aug 14, 2026 | K261646 | Redermax® Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd., CN | FRO |
| Aug 14, 2026 | K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter Medtronic Ireland, IE | LOX |
| Aug 14, 2026 | K261228 | QuickVision Ultimate rTMS Brain Ultimate, Inc. | OBP |
| Aug 14, 2026 | K260898 | Transpara (2.1.0) Screenpoint Medical B.V., NL | QDQ |
| Aug 14, 2026 | K260559 | NHanceIT IMDS Operation B.V., NL | DQY |
| Aug 14, 2026 | K260438 | Vital Signs Monitor (CLEO2) Infinium Medical, Inc. | MWI |
| Aug 14, 2026 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Mon Empatica S.r.l., IT | GYD |
| Aug 14, 2026 | K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) BMC Medical Co., Ltd., CN | CAW |
| Aug 14, 2026 | K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) Jiangsu Enjosim Medical Technology Co., Ltd., CN | FMF |
| Aug 14, 2026 | K253562 | medilogFD Schiller AG, CH | MWJ |
| Aug 13, 2026 | K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set CERENOVUS, Inc. | NRY |
| Aug 13, 2026 | K261626 | UltraPrint Flexible Denture UV Guangzhou Heygears IMC., Inc., CN | EBI |
| Aug 13, 2026 | K261499 | TrachFlush Aw Technologies Aps, DK | BSK |
| Aug 13, 2026 | K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) Freyja Healthcare, LLC | GCJ |
| Aug 13, 2026 | K261061 | BP Go (BPP-855) Wellvii, Inc. | DXN |
| Aug 13, 2026 | K260907 | BIS Advance pEEG Module Covidien LP | OLW |
| Aug 13, 2026 | K260413 | Levo Gen 2 Tinnitus Therapy System Levo Medical Corporation, CA | KLW |
| Aug 13, 2026 | K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM Mikron Makina San. ve Tic. Ltd. Sti., TR | HRS |
| Aug 13, 2026 | K260211 | Dashboard (P007000) Hill-Rom, Inc. | MSX |
| Aug 13, 2026 | K254201 | Any-Cem Mediclus Co., Ltd., KR | EMA |
| Aug 13, 2026 | K253808 | AIR Recon DL GE Medical Systems | LNH |
| Aug 13, 2026 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution Menicon Co, Ltd., JP | LPN |
| Aug 13, 2026 | K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) Beijing Winkonlaser Technology Limited, CN | NGX |
| Aug 13, 2026 | K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-629 Joytech Healthcare Co. , Ltd., CN | DXN |
| Aug 12, 2026 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) Hologic, Inc. | KNW |
| Aug 12, 2026 | K262406 | EluPro Antibiotic-Eluting BioEnvelope Boston Scientific | FTM |
| Aug 12, 2026 | K262399 | Millipede System Perfuze, Ltd., IE | NRY |
| Aug 12, 2026 | K262392 | APRO 35 Swift Catheter Alembic, LLC | DQY |
| Aug 12, 2026 | K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing Alembic, LLC | NRY |
| Aug 12, 2026 | K262344 | Large Compression Screws TriMed, Inc. | HWC |
| Aug 12, 2026 | K261916 | NeuroQuant PET Cortechs Labs, Inc. | LLZ |
| Aug 12, 2026 | K261170 | BA-004CC Fujifilm Corporation, JP | ITX |
| Aug 12, 2026 | K260944 | ManaCold Compression System Manamed, LLC | IRP |
| Aug 12, 2026 | K260086 | CadAI-B Dx BeamWorks, Inc., KR | QDQ |
| Aug 12, 2026 | K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pul Hangzhou Ruidi Biotechnology , Ltd., CN | OAB |
| Aug 12, 2026 | K253417 | Masimo Root Monitoring System Masimo Corporation | MWI |
| Aug 12, 2026 | K251641 | GF-310R Multigas Unit (GF-310R) Nihon Kohden Corporation, JP | CCK |
| Aug 11, 2026 | K262472 | Stelo Glucose Biosensor System Dexcom, Inc. | SBH |
| Aug 11, 2026 | K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) Beijing Nubway S&T Co., Ltd., CN | GEX |
| Aug 11, 2026 | K261398 | Dexter L6 System Distalmotion SA, CH | SDD |
| Aug 11, 2026 | K261115 | VR® Personal Protective Level 4 Gown (VR Gowns) PolyConversions, Inc. | QPC |