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 |
|---|---|---|---|
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | May 9, 2026 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | Carlsmed, Inc. | May 9, 2026 |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | May 8, 2026 |
| K260788 | Smylio Aligners | Smylio, Inc. | May 8, 2026 |
| K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | May 8, 2026 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | May 8, 2026 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | May 8, 2026 |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | May 8, 2026 |
| K253679 | Hydro Irrigation System | Stryker Instruments | May 8, 2026 |
| K253396 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | May 8, 2026 |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | May 8, 2026 |
| K253013 | Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co., Ltd. | May 8, 2026 |
| K252621 | DeepSkin (DEP100) | El Global Trade, Ltd. | May 8, 2026 |
| K252617 | MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. | May 8, 2026 |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | Zeus Scientific | May 8, 2026 |
| DEN250013 | Modius Spero | Neurovalens Limited | May 8, 2026 |
| P250039 | LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus | DiaSorin, Inc. | May 7, 2026 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | May 7, 2026 |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | May 7, 2026 |
| K254276 | Lynx Aspiration Catheter System | QApel Medical, Inc. | May 7, 2026 |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | May 7, 2026 |
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | May 7, 2026 |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | May 7, 2026 |
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle | Galvanize Therapeutics, Inc. | May 7, 2026 |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | Globus Medical, Inc. | May 7, 2026 |
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | May 7, 2026 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | May 6, 2026 |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | Teleflex Medical, LLC | May 6, 2026 |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | May 6, 2026 |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | May 6, 2026 |
