FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23641–23664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2019
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation...
K182250 · NEY
AngioDynamics, Inc.
General & Plastic Surgery · 192d
Cleared Feb 28, 2019
Digital Thermometer
K182629 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 157d
Cleared Feb 28, 2019
Lifetech Cardio Model 8301 Temporary Pacemaker
K182839 · DTE
Shenzhen Lifetech Cardio Medical...
Cardiovascular · 142d
Cleared Feb 28, 2019
QUANTIEN Measurement System
K183099 · DQK
St. Jude Medical (Now Abbott Medical)
Cardiovascular · 113d
Cleared Feb 28, 2019
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue...
K183313 · MVM
Euroimmun Us, Inc.
Immunology · 91d
Cleared Feb 28, 2019
FUJIFILM Endoscope Model EG-530N
K183686 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 62d
Cleared Feb 27, 2019
AeroPro Cordless Prophy System
K180682 · EKX
Premier Dental Company Products
Dental · 349d
Cleared Feb 27, 2019
Lympha Press Optimal Plus
K182003 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 216d
Cleared Feb 27, 2019
PAT (Pain Alleviation Technologies)
K182267 · NUH
Marchan Medical, LLC
Neurology · 190d
Cleared Feb 27, 2019
FlowMet-R
K182494 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 169d
Cleared Feb 27, 2019
uPMR 790
K183014 · OUO
Shanghai United Imaging Healthcare...
Radiology · 119d
Cleared Feb 27, 2019
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
K183683 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 61d
Cleared Feb 27, 2019
EzDent-i / E2 / Prora View
K190087 · LLZ
Ewoosoft Co., Ltd.
Radiology · 41d
Cleared Feb 27, 2019
FibermarX Radiopaque Tissue Marker
K190155 · IYE
Viscus Biologics, LLC
Radiology · 28d
Cleared Feb 26, 2019
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter...
K181870 · FPA
Wuhan W.E.O Science & Technology...
General Hospital · 229d
Cleared Feb 26, 2019
Omni Instrument Tray
K182052 · KCT
Hologic, Inc.
General Hospital · 210d
Cleared Feb 26, 2019
Body System
K182440 · NGX
A-1 Engineering
Physical Medicine · 172d
Cleared Feb 26, 2019
HEALIX ADVANCE SP PEEK Anchor
K182941 · MBI
Medos International SARL
Orthopedic · 126d
Cleared Feb 26, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K183211 · JOJ
3M Company
General Hospital · 99d
Cleared Feb 26, 2019
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
K183360 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Feb 26, 2019
GrayDuck Stent
K183374 · IYE
Poll Medical, LLC
Radiology · 82d
Cleared Feb 26, 2019
Tyece OTC EMS System
K183454 · NGX
Tyece , Ltd.
Neurology · 75d
Cleared Feb 26, 2019
ClariFix
K190356 · GEH
Arrinex, Inc.
General & Plastic Surgery · 11d
Cleared Feb 25, 2019
SpringTMS
K182976 · OKP
Eneura, Inc.
Neurology · 122d