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 |
|---|---|---|---|
| P250039 | LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus | DiaSorin, Inc. | May 7, 2026 |
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | May 1, 2026 |
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | May 1, 2026 |
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | May 1, 2026 |
| K260819 | Any-Com Seal | Mediclus Co., Ltd. | May 1, 2026 |
| K260314 | Ancora-SB | Aspero Medical, Inc. | May 1, 2026 |
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | May 1, 2026 |
| K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | May 1, 2026 |
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | May 1, 2026 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | May 1, 2026 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | May 1, 2026 |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | May 1, 2026 |
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | May 1, 2026 |
| K253326 | Oxiplex | Fziomed, Inc. | May 1, 2026 |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | May 1, 2026 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | May 1, 2026 |
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | May 1, 2026 |
| K252475 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | May 1, 2026 |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | May 1, 2026 |
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | May 1, 2026 |
| DEN240075 | Prolystica Pass Thru Disinfectant Wipes | Steris | May 1, 2026 |
| K261404 | UltraEZ | Ultradent Products, Inc. | Apr 30, 2026 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | Apr 30, 2026 |
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | Apr 30, 2026 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | Apr 30, 2026 |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | Apr 30, 2026 |
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | Apr 30, 2026 |
| K253436 | c-med0 alpha | Cosinuss GmbH | Apr 30, 2026 |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. | Apr 30, 2026 |
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | Apr 30, 2026 |
