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
149953–149976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1985
ANAEROBE KIT
K850052 · JSP
Austin Biological Laboratories
Microbiology · 56d
Cleared Mar 05, 1985
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
K850079 · LCX
Bioclinical Systems, Inc.
Chemistry · 54d
Cleared Mar 05, 1985
CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS
K850131 · GXY
Consolidated Medical Equipment, Inc.
Neurology · 50d
Cleared Mar 05, 1985
SPORDEX CULTURE MEDIA
K850143 · JSC
American Sterilizer Co.
Microbiology · 50d
Cleared Mar 05, 1985
ISOCONTROL SERUM CK-MB
K850213 · JJT
Sclavo, Inc.
Chemistry · 49d
Cleared Mar 05, 1985
ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM
K850221 · KIT
Hazleton Research Products, Inc.
Microbiology · 42d
Cleared Mar 05, 1985
HANKS' MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED-
K850222 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
WAYMOUTH'S MEDIUM MB 752/1
K850224 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
RPMI-1603 MEDIUM
K850229 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
RPMI-1634 MEDIUM
K850230 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
ALPHA MEM MEDIUM W/O NUCLEOSIDES
K850231
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
BCS GLUCOSE COLORIMETRIC TEST
K850257 · CGA
Bioclinical Systems, Inc.
Chemistry · 42d
Cleared Mar 05, 1985
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
K850298 · FEO
Cabot Medical Corp.
Gastroenterology & Urology · 40d
Cleared Mar 05, 1985
DISPOS. CONDUCTIVE ADHESIVE TENS PAD
K850311 · GXY
Consolidated Medical Equipment, Inc.
Neurology · 39d
Cleared Mar 05, 1985
NEBULIZER TREATMENT KIT
K850320
Dhd Medical Products Div. Diemolding...
Cardiovascular · 36d
Cleared Mar 05, 1985
WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D
K850359 · LDM
Millipore Corp.
Chemistry · 34d
Cleared Mar 05, 1985
GLUCOSE - TRINDER- REAGENT
K850364 · CGA
Sigma Chemical Co.
Chemistry · 34d
Cleared Mar 05, 1985
DESERET EPIDURAL CATHETER
K850439 · BSO
Parke-Davis Co.
Anesthesiology · 28d
Cleared Mar 05, 1985
DU PONT DIGOXIN ASSAY CALIBRATOR
K850457 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Mar 05, 1985
DUPONT DIGOXIN ASSAY REAGENTS
K850458 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Mar 05, 1985
OVU STICK SELF-TEST -MODIFICATION
K850480 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 34d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR HAPTOGLOBIN
K850584 · DAD
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR COMPLEMENT C3
K850588 · CZW
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR TRANSFERRIN
K850589 · DDG
Applications Lab
Immunology · 20d