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 |
|---|---|---|---|
| P230038 | AbsorbaSeal 5.6.7F Vascular Closure Device | Cyndrx, LLC | Jun 5, 2026 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | Jun 5, 2026 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | Jun 5, 2026 |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC | Jun 5, 2026 |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Jun 5, 2026 |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | Jun 5, 2026 |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | Jun 5, 2026 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Jun 5, 2026 |
| K254086 | EyeBOX SNAP | Oculogica, Inc. | Jun 5, 2026 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | Jun 5, 2026 |
| K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | Jun 5, 2026 |
| K253204 | Catalyze | BioTissue Holdings, Inc. | Jun 5, 2026 |
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | Jun 5, 2026 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | Jun 5, 2026 |
| K251684 | Alma TED+ System | Alma Lasers, Inc. | Jun 5, 2026 |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | Jun 5, 2026 |
| K261519 | Sonio Suspect | Sonio | Jun 4, 2026 |
| K261510 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | Jun 4, 2026 |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | Jun 4, 2026 |
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | Jun 4, 2026 |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | Jun 4, 2026 |
| K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | Jun 4, 2026 |
| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | Jun 4, 2026 |
| K254209 | Radius VSM and Accessories | Masimo Corporation | Jun 4, 2026 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | Jun 4, 2026 |
| K253984 | Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | Jun 4, 2026 |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | Jun 4, 2026 |
| K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | Jun 4, 2026 |
| K253553 | Orion | Resmed Corp | Jun 4, 2026 |
| K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | Jun 4, 2026 |
