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
28513–28536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2017
Ultimax-i, DREX-UI80 V1.60
K170832 · OWB
Toshibamedical Systems Corporation
Radiology · 123d
Cleared Jul 21, 2017
3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
K171003 · FRC
3M Company
General Hospital · 108d
Cleared CT Jul 21, 2017
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File...
K171441 · OZN
Luminex Corporation
Microbiology · 66d
Cleared Jul 21, 2017
Vantage Elan 1.5T, V4.0
K171597 · LNH
Toshibamedical Systems Corporation
Radiology · 51d
Cleared Jul 21, 2017
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16),...
K171753 · MXZ
Leica Biosystems Newcastle, Limited
Pathology · 39d
Cleared Jul 21, 2017
External Moisturizing Gel
K171855 · NUC
Combe Incorporated
Obstetrics & Gynecology · 30d
Cleared Jul 20, 2017
CADD® Infusion Disposables Portfolio with NRFit™ connectors
K162219 · PWH
Smiths Medical Asd, Inc.
General Hospital · 346d
Cleared Jul 20, 2017
DORA Disposable A.V. Fistula Needle Sets
K163025 · FIE
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 262d
Cleared Jul 20, 2017
SIGN IM Nail
K163589 · HSB
Sign Fracture Care International
Orthopedic · 212d
Cleared Jul 20, 2017
Microlife Digital Infrared Ear Thermometer
K170219 · FLL
Microlife Intellectual Property GmbH
General Hospital · 176d
Cleared Jul 20, 2017
dynaMX Intramedullary Implant
K170326 · HTY
Arthrex, Inc.
Orthopedic · 168d
Cleared Jul 20, 2017
CONCORDE LIFT
K171425 · MAX
Medos International SARL
Orthopedic · 66d
Cleared Jul 20, 2017
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical...
K171439 · KWQ
Medos International SARL
Orthopedic · 65d
Cleared Jul 20, 2017
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
K171616 · LZA
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 49d
Cleared Jul 20, 2017
GelPOINT Path Transanal Access Platform
K171701 · FER
Applied Medical Resources Corp.
Gastroenterology & Urology · 42d
Cleared CT Jul 19, 2017
Dario Blood Glucose Monitoring System
K163159 · NBW
Labstyle Innovations, Ltd.
Chemistry · 251d
Cleared CT Jul 19, 2017
XPress BCD Breast Compression Device
K163388 · POY
Xpress Bcd, LLC
General & Plastic Surgery · 229d
Cleared Jul 19, 2017
OLINDA EXM
K163687 · IYX
Hermes Medical Solutions AB
Radiology · 203d
Cleared Jul 19, 2017
CARDIOVIT FT-1
K170182 · DPS
Schiller AG
Cardiovascular · 177d
Cleared Jul 19, 2017
Disposable Standard Clamp
K170379 · GCJ
Standard Bariatrics
General & Plastic Surgery · 162d
Cleared Jul 19, 2017
Graftgun Universal Graft Delivery System
K170675 · FMF
SurGenTec, LLC
General Hospital · 135d
Cleared Jul 19, 2017
Mini Stick ENVI Non-Vascular Introducer Kit
K170775 · DYB
AngioDynamics, Inc.
Cardiovascular · 127d
Cleared Jul 19, 2017
POD Packing Coil
K170852 · HCG
Penumbra, Inc.
Neurology · 119d
Cleared Jul 19, 2017
Embrace Neonatal MRI System
K170978 · LNH
Aspect Imaging, Ltd.
Radiology · 107d