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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
82417–82440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2000
CLEARFIL ST OPAQUER
K001913 · EBF
Kuraray Company, Ltd.
Dental · 42d
Cleared Aug 04, 2000
CERALAS D10 810NM LASER, MODEL CERALAS D10-60
K001975 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 36d
Cleared Aug 04, 2000
EEI SLUSH PAN DRAPE
K001994 · KKX
Eagle Endoscopic, Inc.
General Hospital · 35d
Cleared Aug 04, 2000
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL...
K002107 · MVM
Scimedx Corp.
Immunology · 23d
Cleared Aug 04, 2000
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · IOR
Invacare Corp.
Physical Medicine · 16d
Cleared Aug 04, 2000
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · FRG
Allegiance Healthcare Corp.
General Hospital · 683d
Cleared Aug 04, 2000
MICROTARGETING ELECTRODE
K991522 · GZL
FHC, Inc.
Neurology · 459d
Cleared Aug 04, 2000
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971 · HTY
Arthrex, Inc.
Orthopedic · 420d
Cleared Aug 04, 2000
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR...
K992133 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 408d
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · JXG
Radionics, Inc.
Neurology · 399d
Cleared Aug 04, 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · HWC
Stryker Endoscopy
Orthopedic · 317d
Cleared Aug 04, 2000
R.TEST EVOLUTION
K993788 · MLO
Novacor Div.
Cardiovascular · 269d
Cleared Aug 04, 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Aug 04, 2000
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
K994400 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Aug 03, 2000
BREAS PV 100 CPAP SYSTEM
K001553 · BZD
Vital Signs, Inc.
Anesthesiology · 77d
Cleared Aug 03, 2000
TAMPONS
K001641 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 65d
Cleared Aug 03, 2000
WATER PURIFIER
K001878 · EIA
Waterclave, LLC
Dental · 44d
Cleared Aug 03, 2000
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
K002053 · HAW
Orthosoft, Inc.
Neurology · 28d
Cleared Aug 03, 2000
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 13d
Cleared Aug 03, 2000
VYGON 2 FR EPICUTANEO PUR-CATHETER
K993052 · LJS
Vygon Corp.
General Hospital · 325d
Cleared Aug 03, 2000
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR,...
K993442 · LJS
Vygon Corp.
General Hospital · 296d
Cleared Aug 03, 2000
DETRUSAN 500
K994109 · KPI
Innovamed USA, Inc.
Gastroenterology & Urology · 241d
Cleared Aug 03, 2000
EXCELSIOR 1018 MICROCATHETER
K994155 · KRA
Boston Scientific, Target
Cardiovascular · 238d
Cleared Aug 02, 2000
LUBRIGEL PERSONAL LUBRICANT
K001077 · NUC
Sheffield Laboratories, Div. of Faria...
Obstetrics & Gynecology · 120d