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 |
|---|---|---|---|
| K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | Jul 26, 2026 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | Jul 26, 2026 |
| K260382 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | Jul 25, 2026 |
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | Jul 25, 2026 |
| P250029 | SimpleScreen CRC | Freenome, LLC | Jul 24, 2026 |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | Jul 24, 2026 |
| K262383 | LumenCare Azure | Nucletron B.V. | Jul 24, 2026 |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | Philips Medical Systems Nederland B.V. | Jul 24, 2026 |
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | Jul 24, 2026 |
| K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | Jul 24, 2026 |
| K262152 | VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. | Jul 24, 2026 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | Jul 24, 2026 |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | Jul 24, 2026 |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | Jul 24, 2026 |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | Jul 24, 2026 |
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | Jul 24, 2026 |
| K261349 | SwiftMR | Airs Medical, Inc. | Jul 24, 2026 |
| K261312 | Temporary Keratoprosthesis (QuickSet TKP™) | Eyekon Medical, Inc. | Jul 24, 2026 |
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland, Ltd. | Jul 24, 2026 |
| K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | Jul 24, 2026 |
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | Jul 24, 2026 |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | Hycor Biomedical | Jul 24, 2026 |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | Jul 24, 2026 |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | Jul 24, 2026 |
| K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | Jul 24, 2026 |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | Jul 24, 2026 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | Jul 24, 2026 |
| K260259 | DiscreetDuo™ Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | Jul 24, 2026 |
| K260192 | DIANA | ROPCA ApS | Jul 24, 2026 |
| K254180 | PerfusiX-Imaging | LIMIS Development B.V. | Jul 24, 2026 |
