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 |
|---|---|---|---|
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | Jul 31, 2026 |
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | Jul 31, 2026 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | Jul 31, 2026 |
| K261912 | SnØreNegatØr | DnB Innovations, LLC | Jul 31, 2026 |
| K261854 | xvision Spine system | Augmedics, Ltd. | Jul 31, 2026 |
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | Jul 31, 2026 |
| K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | Jul 31, 2026 |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | Jul 31, 2026 |
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | Shanghai Hulu Devices Co., Ltd. | Jul 31, 2026 |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | Jul 31, 2026 |
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | Jul 31, 2026 |
| K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | Jul 31, 2026 |
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | Jul 31, 2026 |
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | Jul 31, 2026 |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | Jul 31, 2026 |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | Jul 31, 2026 |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | Jul 31, 2026 |
| K260607 | Shield System (Siemens 30x40) | Radiaction , Ltd. | Jul 31, 2026 |
| K254042 | WatchPAT SW | Itamar Medical , Ltd. | Jul 31, 2026 |
| K253835 | Affinity | Hermes Medical Solutions AB | Jul 31, 2026 |
| K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | Jul 31, 2026 |
| K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | Jul 31, 2026 |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | Jul 31, 2026 |
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | Jul 31, 2026 |
| P250036 | PGDx elio tissue complete CDx | Personal Genome Diagnostics, Inc. | Jul 30, 2026 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | Jul 30, 2026 |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | Philips Medical Systems Nederland B.V. | Jul 30, 2026 |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | Jul 30, 2026 |
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | Jul 30, 2026 |
| K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | Jul 30, 2026 |
