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
156601–156624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1983
CODE BLUE MANUAL RESUSCITATOR
K831885 · BTM
Vital Signs, Inc.
Anesthesiology · 87d
Cleared Sep 01, 1983
DAC-CEL HCG-MCA KIT RD52
K831073 · CFL
Wellcome Diagnostics
Chemistry · 150d
Cleared Sep 01, 1983
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · MBV
Depuy, Inc.
Orthopedic · 119d
Cleared Sep 01, 1983
FIRST AID KITS
K831795 · KDD
I M, Inc.
General & Plastic Surgery · 90d
Cleared Sep 01, 1983
VIVONEX TUNGSTEN TIP TUBE-BRAIDED
K831968 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 73d
Cleared Sep 01, 1983
VIVONEX TUNGSTEN TIP TUBE-WOUND
K831969 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 73d
Cleared Sep 01, 1983
VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE
K831971 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 73d
Cleared Sep 01, 1983
STERILE DISPOSABLE NEEDLES
K832102 · FMI
Lee Medical Intl., Inc.
General Hospital · 70d
Cleared Sep 01, 1983
PHADEBACT STREP POSITIVE CONTROLS
K832248 · GTY
Pharmacia, Inc.
Hematology · 52d
Cleared Sep 01, 1983
HEMOGLOBINOMETER
K832288 · KMG
Mallinckrodt Critical Care
Hematology · 50d
Cleared Sep 01, 1983
SOLO-TACH
K832292 · DYH
Dentsply Intl.
Dental · 50d
Cleared Sep 01, 1983
HYDROXYPROGESTERONE-17
K832297 · JLS
Diagnostics Biochem Canada, Inc.
Chemistry · 50d
Cleared Sep 01, 1983
ROGOSA BROTH
K832310 · JSD
Oxoid U.S.A., Inc.
Microbiology · 49d
Cleared Sep 01, 1983
MAGIC TSH 125I RADIOIMMUNOASSAY
K832313 · JLW
Corning Medical & Scientific
Chemistry · 49d
Cleared Sep 01, 1983
CARDIZYME PLUS LD #65094/93
K832314 · CFE
Em Industries, Inc.
Chemistry · 49d
Cleared Sep 01, 1983
FEEDBACK EMG SYSTEM PE-020
K832333 · HCC
Bio-Feedback Systems, Inc.
Neurology · 45d
Cleared Sep 01, 1983
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK
K832357 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 45d
Cleared Sep 01, 1983
TCBS AGAR
K832365 · JSI
Granite Diagnostics, Inc.
Microbiology · 45d
Cleared Sep 01, 1983
CORNING MAGIC SINGLE STEP FREE T4
K832381 · CEC
Corning Medical & Scientific
Chemistry · 44d
Cleared Sep 01, 1983
A-GENT PHERYTOIN
K832419 · DIP
Abbott Laboratories
Toxicology · 41d
Cleared Sep 01, 1983
FACS ANALYZER
K832420 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 41d
Cleared Sep 01, 1983
OHIO 5400 VOLUME MONITOR
K832565 · BZK
Airco/Ohio Medical Products
Anesthesiology · 30d
Cleared Aug 31, 1983
HANCOCK PERICARDIAL PATCH
K830863 · DXZ
Extracorporeal Medical Specialities,...
Cardiovascular · 166d
Cleared Aug 31, 1983
ROYALE II
K831095 · EBI
Factor, Ii, Inc.
Dental · 149d