FDA 510(k) Search and Medical Device Explorer
Search and browse FDA-cleared medical devices, 510(k) submissions, De Novo classifications, PMA records, product codes, review panels, and 21 CFR regulation groupings.
Review Panels
- Anesthesiology (AN)
- Clinical Chemistry (CH)
- Cardiovascular (CV)
- Dental (DE)
- Ear, Nose, Throat (EN)
- Gastroenterology, Urology (GU)
- Hematology (HE)
- General Hospital (HO)
- Immunology (IM)
- Medical Genetics (MG)
- Microbiology (MI)
- Neurology (NE)
- Obstetrics/Gynecology (OB)
- Ophthalmic (OP)
- Orthopedic (OR)
- Pathology (PA)
- Physical Medicine (PM)
- Radiology (RA)
- General, Plastic Surgery (SU)
- Clinical Toxicology (TX)
Recent Decisions
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K262120 | Avara Viewer | Avara Software | Jul 10, 2026 |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation | Jul 10, 2026 |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | Jul 10, 2026 |
| 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 | Jul 10, 2026 |
| K261306 | AI Contouring (VA10A) | Varian Medical Systems | Jul 10, 2026 |
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | Jul 10, 2026 |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | Jul 10, 2026 |
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | Jul 10, 2026 |
| K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | Jul 10, 2026 |
| 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 | Jul 10, 2026 |
| K260880 | SedLine Sedation Monitor | Masimo Corporation | Jul 10, 2026 |
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Jul 10, 2026 |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | Jul 10, 2026 |
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | Jul 10, 2026 |
| 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. | Jul 10, 2026 |
| K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | Jul 10, 2026 |
| P250016 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | Jul 9, 2026 |
| K261988 | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC | Jul 9, 2026 |
| 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. | Jul 9, 2026 |
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | Jul 9, 2026 |
| K261569 | UbiqVue™ 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | Jul 9, 2026 |
| K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | Jul 9, 2026 |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | Jul 9, 2026 |
| K261166 | DIA-CEM | DiaDent Group International | Jul 9, 2026 |
| K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | Procept Biorobotics | Jul 9, 2026 |
| K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter | MedSource Labs, LLC | Jul 9, 2026 |
| K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | Jul 9, 2026 |
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | Jul 9, 2026 |
| K253899 | 3D-Anywhere | Provect.AI | Jul 9, 2026 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | Jul 9, 2026 |
