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
161473–161496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · DXY
Intermedics, Inc.
Cardiovascular · 14d
Cleared Apr 08, 1982
MARK 500 SYSTEM
K812416
Kallestad Laboratories, Inc.
Obstetrics & Gynecology · 227d
Cleared Apr 08, 1982
GLYCO-GEL TEST KIT
K820279 · LCP
Pierce Chemical Co.
Hematology · 65d
Cleared Apr 08, 1982
CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV
K820298 · DHX
Ventrex Laboratories, Inc.
Immunology · 63d
Cleared Apr 08, 1982
SPIRAL STONE AND RETRIEVAL BASKETS
K820429 · OCZ
American Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 08, 1982
DIATHERMIC SNARES
K820430 · KNS
American Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 08, 1982
MEM VITAMINS (100X
K820509 · KIT
Dutchland Laboratories, Inc.
Chemistry · 44d
Cleared Apr 08, 1982
DISPO FIBRIN PIPET TIPS B4182-2
K820532 · GIE
American Scientific Products
Hematology · 37d
Cleared Apr 08, 1982
B4182-1
K820533 · GIE
American Scientific Products
Hematology · 37d
Cleared Apr 08, 1982
WALK-A-CYCLE
K820711 · ITJ
Walk-A-Cycle Division
Physical Medicine · 24d
Cleared Apr 08, 1982
EMIT-ST URINE COCAINE METABOLITE ASSAY
K820773 · DID
Syva Co.
Toxicology · 16d
Cleared Apr 08, 1982
ASO SURE
K820785 · GTQ
Analytical Products, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
ASO SURE PLUS
K820786 · GTQ
Analytical Products, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
K820787 · JCM
Helena Laboratories
Hematology · 16d
Cleared Apr 08, 1982
#4005 TSA SLANT-TUBED MEDIA
K820791 · JSG
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#19041-150X15MM MUELLER HINTON
K820792 · JTZ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#1904L MUELLER HINTON W/5% SHEEP BLOOD
K820793 · JTZ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#19012 CHOCOLATE MUELLER HINTON-150X15MM
K820794 · JTZ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#4006 TSB-TUBED MEDIA
K820795 · JSC
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#4001 TUBED MEDIA - FLUID THIOGLYCOLLATE
K820796 · JSC
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#50001 QUADE DIAGNOSTIC SYSTEM
K820797 · JSI
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2001 HEKTOEN
K820798 · JSI
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2002 MANNITOL SALT AGAR
K820799 · JSJ
Biomedica, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
#2006 SALMONELLA SHIGELLA AGAR
K820800 · JSI
Biomedica, Inc.
Microbiology · 16d