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
38497–38520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2014
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE,...
K133794 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 53d
Cleared Feb 03, 2014
SHOOCIN INTRODUCER KIT
K123475 · DYB
Lepu Medical Technology (Beijing)...
Cardiovascular · 447d
Cleared Feb 03, 2014
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249 · MEB
I-Flow, LLC
General Hospital · 278d
Cleared Feb 03, 2014
DEROYAL SPINE SPACER SYSTEM
K131292 · MAX
Deroyal Industries, Inc.
Orthopedic · 273d
Cleared Feb 03, 2014
MEDLINE SHARPS CONTAINER
K132767 · MMK
Medline Industries, Inc.
General Hospital · 152d
Cleared Feb 03, 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
K133151 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 109d
Cleared Feb 03, 2014
JULIET LL LATERAL LUMBAR CAGE
K133557 · MAX
Spineart
Orthopedic · 76d
Cleared Jan 31, 2014
XIRALITE FLOURESCENCE IMAGING SYSTEM X4
K130003 · IZI
Mivenion GmbH
Radiology · 394d
Cleared Jan 31, 2014
MEDSOURCE IV SAFETY CATHETER
K131555 · FOZ
Medsource International, LLC
General Hospital · 247d
Cleared Jan 31, 2014
AVD RIGHT RADIAL DRAPE
K131571 · KKX
Advanced Vascular Dynamics
General Hospital · 246d
Cleared Jan 31, 2014
ENLIGHTN RENAL GUIDE CATHETER
K131592 · DQY
St. Jude Medical, Inc.
Cardiovascular · 242d
Cleared Jan 31, 2014
VESALIUS
K131696 · GEI
Telea Electronic Engineering Srl
General & Plastic Surgery · 235d
Cleared Jan 31, 2014
RAYPEX 6
K131907 · LQY
Dentsply International, Inc.
Dental · 219d
Cleared Jan 31, 2014
VITA SUPRINITY(R)
K132070 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 212d
Cleared Jan 31, 2014
LINA GOLD LOOP HC
K132135 · KNF
Lina Medical Aps
Obstetrics & Gynecology · 205d
Cleared Jan 31, 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K132221 · LYZ
Shandong Haoyu Medical Products Co.,...
General Hospital · 198d
Cleared Jan 31, 2014
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
K132356 · EGS
Scican GmbH
Dental · 186d
Cleared Jan 31, 2014
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
K132792 · MMK
Daniels Sharpsmart, Inc.
General Hospital · 147d
Cleared Jan 31, 2014
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
K132807 · MWI
Welch Allyn, Inc.
Cardiovascular · 144d
Cleared Jan 31, 2014
LOGIQ F SERIES
K133034 · IYN
Ge Healthcare
Radiology · 127d
Cleared Jan 31, 2014
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K133038 · NGZ
Trek Diagnostic Systems
Microbiology · 127d
Cleared Jan 31, 2014
VARIAN MULTILEAF COLLIMATOR
K133240 · IYE
Varian Medical Systems, Inc.
Radiology · 102d
Cleared Jan 31, 2014
WONDFO RAPID STREP A TEST
K133343 · GTY
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 93d
Cleared Jan 31, 2014
RADIANCE V2
K133655 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 65d