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

Filters: Cleared only ×
176,076 results
166321–166344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · JJX
Beckman Instruments, Inc.
Chemistry · 44d
Cleared Oct 10, 1980
BAKER DIAG. ULTRARATE CHLORIDE KIT
K802080 · JFS
J.T. Baker Chemical Co.
Chemistry · 43d
Cleared Oct 10, 1980
AMERICAN MONITOR MAGNESIUM #'S 1036&4021
K802091 · JGJ
American Monitor Corp.
Chemistry · 38d
Cleared Oct 10, 1980
ORTHO SPECTRUM
K802094 · GKL
Ortho Instruments
Hematology · 38d
Cleared Oct 10, 1980
GORE-TEX VASCULAR GRAFT
K802095 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 38d
Cleared Oct 10, 1980
SELF-RECORDING ADMITTANCE METER 709
K802097 · ETY
Amplaid USA, Inc.
Ear, Nose, Throat · 38d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
K802108 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
K802109 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
TESTOSTERONE RADIOIMMUNOASSY KIT
K802135 · CDZ
Radioimmunoassay, Inc.
Chemistry · 36d
Cleared Oct 10, 1980
DELTA TEST TRIGLYCERIDES
K802136 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
K802141 · JPK
American Dade
Hematology · 35d
Cleared Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
K802142 · JPK
American Dade
Hematology · 35d
Cleared Oct 10, 1980
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
K802143 · JPK
American Dade
Hematology · 35d
Cleared Oct 10, 1980
AQUASONIC 100 ULTRASOUND TRANS. GEL,
K802146 · IYO
Parker Laboratories, Inc.
Radiology · 35d
Cleared Oct 10, 1980
REAGENTS USED-QUAN. MEASURE OF SERUM
K802154 · CIG
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
REAGENTS SERUM SODIUM USING THE TECH.
K802155 · JGS
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
REAGENTS SERUM CREATINE USING TECHICON
K802156 · CGX
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BCG REAGENT SERUM ALBUMIN W/TECHNICON
K802157 · CIX
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
POSTASSIUM BUFFER SOL. & WASH SOLUTION
K802158 · CEM
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS
K802159 · CEO
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BUN COLOR REAGENT & BUN ACID USED
K802160 · CDW
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BIURET REAGENT & TOTAL PROTEIN BLANK SOL
K802161 · CEK
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
K802162 · KMS
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT
K802163 · CHJ
Panmed, Inc.
Chemistry · 32d