FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
28513–28536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2017
DSM Biomedical Dental Bone Graft
K170245 · NPM
Kensey Nash Corporation Dba Dsm...
Dental · 110d
Cleared May 16, 2017
A-View
K170338 · ITX
Stroke2prevent B.V.
Radiology · 103d
Cleared May 16, 2017
KARL STORZ ShuntScope
K170462 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 90d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481 · PQZ
Hardy Diagnostics
Microbiology · 89d
Cleared May 16, 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496 · NKB
Stryker Corporation
Orthopedic · 88d
Cleared May 16, 2017
SIROLaser Advance+
K170500 · GEX
Dentsply Sirona
General & Plastic Surgery · 84d
Cleared May 16, 2017
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
K170575 · LYZ
Ever Global (Vietnam) Enterprise Corp
General Hospital · 78d
Cleared May 16, 2017
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K170680 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 71d
Cleared May 16, 2017
Arthrex Knotless SutureTak Anchor
K171020 · MBI
Arthrex, Inc.
Orthopedic · 41d
Cleared May 16, 2017
VITROS Immunodiagnostic Products Insulin Calibrators
K171168 · JIT
Ortho-Clinical Diagnostics
Chemistry · 25d
Cleared May 16, 2017
Tyber Medical Wedge System
K171327 · PLF
Tyber Medical, LLC
Orthopedic · 11d
Cleared May 15, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
K153410 · SEL
3M Company
General & Plastic Surgery · 537d
Cleared May 15, 2017
SS SA Fixture
K163557 · DZE
Osstem Implant Co., Ltd.
Dental · 147d
Cleared May 15, 2017
Dental 5 Multi Diode laser
K163638 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 143d
Cleared May 15, 2017
SPiN Thoracic Navigation System
K170023 · JAK
Veran Medical Technologies, Inc.
Radiology · 132d
Cleared May 15, 2017
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece,...
K170312 · HBC
Medtronic Powered Surgical Solutions
Neurology · 103d
Cleared May 15, 2017
ULTRASHAPE POWER SYSTEM
K170370 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 98d
Cleared May 15, 2017
PNEUMOCLEAR
K170784 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 61d
Cleared May 15, 2017
EVS 2430W, EVS 2430GW
K171137 · MQB
DRTECH Corporation
Radiology · 28d
Cleared May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · KHE
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d
Cleared May 12, 2017
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems...
K161261 · MQL
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 373d
Cleared May 12, 2017
Avazzia
K162392 · NUH
Avazzia, Inc.
Neurology · 259d
Cleared May 12, 2017
Unity Network ID
K170199 · MWI
Ge Healthcare
Cardiovascular · 109d
Cleared May 12, 2017
Belimed Steam Sterilizer MST-H TOP 5000
K170228 · FLE
Belimed AG
General Hospital · 107d