Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
39097–39120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 31, 2014
CO PILOT/REGIUS UNITEA
K133730 · LLZ
Konica Minolta, Inc.
Radiology · 56d
Cleared Jan 31, 2014
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD,...
K133796 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 49d
Cleared Jan 31, 2014
BREEZY ELEGANCE
K133855 · IOR
Sunrise Medical (Us), LLC
Physical Medicine · 43d
Cleared Jan 31, 2014
INTERBODY CAGE SYSTEM
K133967 · MAX
Aurora Spine
Orthopedic · 38d
Cleared Jan 31, 2014
6MP COLOR LCD MONITOR, RADIFORCE RX650
K134002 · LLZ
Eizo Corporation
Radiology · 35d
Cleared Jan 31, 2014
SORIN FLEXTHERM
K140012 · DWC
Sorin Group Deutschland GmbH
Cardiovascular · 29d
Cleared Jan 30, 2014
CARDIOCEL
K130872 · DXZ
Celxcel Pty, Ltd.
Cardiovascular · 307d
Cleared Jan 30, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131344 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 266d
Cleared Jan 30, 2014
CENTURION POCT SYSTEM
K131833 · KWP
Orthofix, Inc.
Orthopedic · 224d
Cleared Jan 30, 2014
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
K132474 · DXO
Acist Medical Systems
Cardiovascular · 176d