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 |
|---|---|---|---|
| K260691 | BTL-699 | BTL Industries, Inc. | Aug 23, 2026 |
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | Aug 22, 2026 |
| K262538 | Artix™ MT;Artix™ Thin-Walled Sheath | Inari Medical, Inc. | Aug 21, 2026 |
| K262127 | DS Core CBCT Anatomy | Dentsply Sirona | Aug 21, 2026 |
| K262089 | Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. | Aug 21, 2026 |
| K262074 | Any-Zircos | Mediclus Co., Ltd. | Aug 21, 2026 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | Aug 21, 2026 |
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | Aug 21, 2026 |
| K261710 | AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors | Apyx Medical Corporation | Aug 21, 2026 |
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | Aug 21, 2026 |
| K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | Aug 21, 2026 |
| K261015 | Solo Scope Colonoscope System | Gi View, Ltd. | Aug 21, 2026 |
| K260643 | Cimilre Dual Max | Cimilre Co., Ltd. | Aug 21, 2026 |
| K260584 | BoneMRI | Mriguidance B.V. | Aug 21, 2026 |
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | Aug 21, 2026 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | Aug 21, 2026 |
| K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | Aug 21, 2026 |
| K253699 | Tempus ECG-PH | Tempus AI, Inc. | Aug 21, 2026 |
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | Aug 21, 2026 |
| DEN250067 | ReneuRx™ (Neural Ice) | Brixton Biosciences | Aug 21, 2026 |
| DEN250026 | Avulux | Matap Ii, LLC | Aug 21, 2026 |
| P250018 | RefluxStop® Device and RefluxStop® Deployment Tool | Implantica CE Reflux , Ltd. | Aug 20, 2026 |
| K262515 | Kneu Platform (V2) | Kneu Health Digital , Ltd. | Aug 20, 2026 |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | Aug 20, 2026 |
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10) | Hardy Diagnostics | Aug 20, 2026 |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | Aug 20, 2026 |
| K261049 | SCALA® TL | Spineart SA | Aug 20, 2026 |
| K260817 | MIRA Surgical System | Virtual Incision | Aug 20, 2026 |
| K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | Aug 20, 2026 |
| K260242 | CPETWise Platform | Medibyt , Ltd. | Aug 20, 2026 |
