FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2809–2832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis...
K243604 · LZA
O&M Halyard, Inc.
General Hospital · 270d
Cleared Aug 18, 2025
Apollo TMS Therapy System
K243539 · OBP
Mag & More GmbH
Neurology · 276d
Cleared Aug 16, 2025
OsteoCentric® UnifiMI® TCS Plating System
K251913 · HRS
OsteoCentric Technologies
Orthopedic · 54d
Cleared Aug 15, 2025
AssureTech Quick Cup Tests
K252259 · NFT
Assure Tech., LLC
Toxicology · 25d
Cleared Aug 15, 2025
CP Relief Wand Rx - TENS/NMES
K252236 · GZJ
N & C Holdings, LLC
Neurology · 29d
Cleared Aug 15, 2025
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative
K251972 · DJG
Healgen Scientific, LLC
Toxicology · 50d
Cleared Aug 15, 2025
Atlas Spine Project X Expandable Posterior Lumbar Interbody System
K251969 · MAX
Atlas Spine, Inc.
Orthopedic · 50d
Cleared Aug 15, 2025
JMS CAVEO A.V. Fistula Needle Set
K251877 · FIE
JMS North America Corporation
Gastroenterology & Urology · 58d
Cleared Aug 15, 2025
FEATHER 01 02 03 04 (Model:01)
K251871 · OHS
Heat IN A Click, LLC
General & Plastic Surgery · 58d
Cleared Aug 15, 2025
Persona Partial Knee
K251834 · HSX
Zimmer Biomet
Orthopedic · 60d
Cleared Aug 15, 2025
VEA Align
K251747 · QIH
Eos Imaging
Radiology · 70d
Cleared Aug 15, 2025
OneRF Trigeminal Nerve Radiofrequency Probes
K251243 · GXI
Neuroone Medical Technologies Corp.
Neurology · 115d
Cleared Aug 15, 2025
Dunamis Screw and Suture Locking System
K250867 · HWC
Dunamis Medical, LLC
Orthopedic · 144d
Cleared Aug 15, 2025
Nerveblox
K250818 · QRG
Smart Alfa Teknoloji San. Ve Tic. A.S.
Anesthesiology · 150d
Cleared Aug 15, 2025
KLS Martin Ixos System
K250620 · HRS
KLS-Martin L.P.
Orthopedic · 168d
Cleared Aug 15, 2025
Helios Dermal Scaffold
K250397 · KGN
Helios Biomedical, Inc.
General & Plastic Surgery · 184d
Cleared Aug 15, 2025
PHAROS
K250170 · KPS
Brightonix Imaging
Radiology · 206d
Cleared Aug 15, 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32...
K250036 · LTT
Beckman Coulter, Inc.
Microbiology · 219d
Cleared Aug 15, 2025
CHLOE BLAST
K243851 · PBH
Fairtility , Ltd.
Obstetrics & Gynecology · 242d
Cleared Aug 15, 2025
Zio® monitor (DFG0001)
K243650 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared Aug 14, 2025
FilmArray GI Control Panel M238
K251526 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared Aug 14, 2025
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A,...
K251176 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 120d
Cleared Aug 14, 2025
Geistlich Bio-Gide
K251062 · NPL
Geistlich Pharma AG
Dental · 132d
Cleared Aug 14, 2025
TRUDERMAL Pro (ZLD-390)
K251012 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 134d