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
30289–30312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Dec 22, 2016
ivWatch
K162478 · PMS
Ivwatch, LLC
General Hospital · 107d
Cleared Dec 22, 2016
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel...
K162721 · NRB
Alliqua Biomedical, Inc.
General & Plastic Surgery · 84d
Cleared Dec 22, 2016
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
K163068 · FAD
Q Urological Corporation
Gastroenterology & Urology · 50d
Cleared Dec 22, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter
K163306 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared Dec 21, 2016
TRACOE Cuff Pressure Monitor
K152778 · BSK
Tracoe Medical GmbH
Anesthesiology · 453d
Cleared CT Dec 21, 2016
Ox-Imager CS
K153426 · MUD
Modulated Imaging, Inc.
Cardiovascular · 392d
Cleared Dec 21, 2016
Sonablate
K160942 · PLP
Sonacare Medical, LLC
Gastroenterology & Urology · 260d
Cleared Dec 21, 2016
Orthodontic Screw
K161197 · OAT
Osstem Implant Co., Ltd.
Dental · 237d
Cleared Dec 21, 2016
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey]...
K161215 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 236d
Cleared Dec 21, 2016
NICO Myriad
K161307 · GEI
Nico Corporation
Obstetrics & Gynecology · 225d
Cleared Dec 21, 2016
DMS Disposable Subdermal Needle Electrodes
K161566 · GXZ
Daehan Medical Systems Co., Ltd.
Neurology · 198d
Cleared Dec 21, 2016
TEETHAN 2.0
K161716 · KZM
Bts S.P.A.
Dental · 183d
Cleared Dec 21, 2016
ulrich Transfer Set
K161723 · PQH
Ulrich GmbH & Co. KG
General Hospital · 182d
Cleared Dec 21, 2016
TelePatch Cardiac Monitor
K161916 · DRG
Medicomp, Inc.
Cardiovascular · 162d
Cleared Dec 21, 2016
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · CFF
Sebia
Immunology · 160d
Cleared Dec 21, 2016
IMSE Cervical Cage
K162003 · ODP
The Institute of Musculoskeletal...
Orthopedic · 154d
Cleared Dec 21, 2016
Scope Buddy Plus Endoscope Flushing Aid
K162128 · FEB
Medivators, Inc.
General Hospital · 142d
Cleared Dec 21, 2016
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · NLH
Innovative Health, LLC
Cardiovascular · 133d
Cleared Dec 21, 2016
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K162259 · LYZ
Zibo Daiyang Plastic Company
General Hospital · 132d
Cleared Dec 21, 2016
IntelliCartTM System
K162421 · JCX
Dornoch Medical Systems
General & Plastic Surgery · 113d
Cleared Dec 21, 2016
EndoVac Pure
K162436 · NYL
Kerr Corporation
Dental · 112d
Cleared Dec 21, 2016
EVS 4343, EVS 4343G
K162555 · MQB
DRTECH Corporation
Radiology · 99d
Cleared Dec 21, 2016
L- OVC
K162677 · EIH
Rhondium, Ltd.
Dental · 86d
Cleared Dec 21, 2016
Evolution Esophageal Stent System – Partially Covered
K162717 · ESW
Cook Ireland, Ltd.
Gastroenterology & Urology · 83d