510(k) Clearances — Page 2
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,607 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K254037 — LungFlow Airway Catheter | Free Flow Medical, Inc. Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260880 — SedLine Sedation Monitor | Masimo Corporation Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253670 — SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard, Inc. Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260902 — Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | Cochlear Americas Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262120 — Avara Viewer | Avara Software Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253480 — Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261949 — NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261041 — ClearSafe Closed System | MedSource Labs, LLC Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261306 — AI Contouring (VA10A) | Varian Medical Systems Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260157 — LifeLens Physiological Monitor | LifeLens Technologies, Inc. Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261166 — DIA-CEM | DiaDent Group International Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253899 — 3D-Anywhere | Provect.AI Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253901 — Millipede88 Access Catheter | Perfuze, Ltd. Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261569 — UbiqVue 2AYe Cardiac System (UX2253) | Lifesignals, Inc. Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252978 — ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261962 — SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | MedSource Labs, LLC Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261471 — Zeta TMS Navigation System | Zeta Surgical, Inc. Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260723 — HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | Procept Biorobotics Thu Jul 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261396 — Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems, Inc. Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261191 — Alians Elbow S | Newclip Technics Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260278 — ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260700 — BlueDop Vascular Expert | BlueDop Medical, Ltd. Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260750 — Virtual Cone (1.0) | Varian Medical Systems, Inc. Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262300 — Denture Base Resin V2 | Formlabs Ohio, Inc. Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254130 — C.A. Medical Interbody Fusion System | C.A. Medical, LLC Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253751 — CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. Wed Jul 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262045 — Luja Soft | Coloplast A.S. Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261812 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | HOYA Lamphun , Ltd. Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261163 — Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261164 — Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253942 — Pulmonex II Xenon System (132-503) | Mirion Technologies (Capintec), Inc. Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260973 — InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253317 — Cytrans Elashield | GC America, Inc. Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261465 — INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260122 — Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |