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
149521–149544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1985
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
K850252 · DXY
Telectronics, Inc.
Cardiovascular · 72d
Cleared Apr 04, 1985
TRAVENOL FLO-GARD 500 IV MONITOR
K850710 · FLN
Travenol Laboratories, S.A.
General Hospital · 41d
Cleared Apr 04, 1985
TANDEM SETS I.V.
K850757 · LHI
Acacia, Inc.
General Hospital · 38d
Cleared Apr 04, 1985
NORELCO DIGITAL MODEL 987 THERMOMETER
K851010 · FLL
Philips Park
General Hospital · 23d
Cleared Apr 04, 1985
NORELCO DIGITAL MODEL 970 THERMOMETER
K851075 · FLL
Philips Park
General Hospital · 17d
Cleared Apr 04, 1985
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
K851081 · DXY
Telectronics, Inc.
Cardiovascular · 17d
Cleared Apr 03, 1985
POLY FLEX IMPLANTABLE PACING LEAD
K802294 · DTB
Intermedics, Inc.
Cardiovascular · 1657d
Cleared Apr 03, 1985
MODEL 486-01 PACEMAKER LEAD
K813135 · DTB
Intermedics, Inc.
Cardiovascular · 1245d
Cleared Apr 03, 1985
MODEL 492-01 PACEMAKER LEAD
K813136 · DTB
Intermedics, Inc.
Cardiovascular · 1245d
Cleared Apr 03, 1985
INTERMEDICS POLYFLEX PACING LEAD #480-01
K820267 · DTB
Intermedics, Inc.
Cardiovascular · 1156d
Cleared Apr 03, 1985
DIMERTEST LATEX
K842277 · GHH
Mabco, Inc.
Hematology · 299d
Cleared Apr 03, 1985
TBM-REAGENT FOR T,B CELL & MONOCYTES
K843062 · LIZ
Bd Becton Dickinson Vacutainer...
Microbiology · 243d
Cleared Apr 03, 1985
ABBOTT TDT EIA
K843908 · CIG
Abbott Laboratories
Chemistry · 182d
Cleared Apr 03, 1985
PROGRAMMABLE PATIENT SIMULATOR
K844464 · DSI
Ramford Labs
Cardiovascular · 134d
Cleared Apr 03, 1985
SENTRY SIGNAL ENURESIS ALARM SYSTEM
K844636 · KPN
Conklin Technology, Inc.
Gastroenterology & Urology · 126d
Cleared Apr 03, 1985
NYTONE ENURETIC ALARM BEDWETTING DEVICE
K844866 · KPN
Nytone Medical
Gastroenterology & Urology · 110d
Cleared Apr 03, 1985
VENOUS RETURN CATHETER SS-1
K845045 · DWF
Dlp, Inc.
Cardiovascular · 96d
Cleared Apr 03, 1985
PUL,MONARY ARTERY VENT CATHETER
K845046 · DWF
Dlp, Inc.
Cardiovascular · 96d
Cleared Apr 03, 1985
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
K850254 · CEW
Cambridge Medical Technology
Chemistry · 71d
Cleared Apr 03, 1985
ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR
K850271 · DQO
Angiomedics, Inc.
Cardiovascular · 70d
Cleared Apr 03, 1985
BED SENTRY, MODEL 50U
K850538 · KPN
Metatech Corp.
Gastroenterology & Urology · 51d
Cleared Apr 03, 1985
PHACOEMULSIFICATION TIP
K850578 · HQC
Ultramed, Inc.
Ophthalmic · 49d
Cleared Apr 03, 1985
DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000
K850580 · IYO
Elscint, Inc.
Radiology · 49d
Cleared Apr 03, 1985
I-L TEST, DIRECT BILIRUBIN SET
K850748 · CIG
Allied Instrumentation Laboratory
Chemistry · 37d