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
140569–140592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1987
COLUMBIA CNA AGAR
K870647 · JSJ
Hardy Media
Microbiology · 60d
Cleared Apr 14, 1987
STAPHYLOCOCCUS 110 AGAR
K870648 · JSI
Hardy Media
Microbiology · 60d
Cleared Apr 14, 1987
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
K870649 · JTZ
Hardy Media
Microbiology · 60d
Cleared Apr 14, 1987
NEOMYCIN ANAEROBIC BLOOD AGAR
K870650 · JSJ
Hardy Media
Microbiology · 60d
Cleared Apr 14, 1987
BIGGY AGAR
K870651 · JSH
Hardy Media
Microbiology · 60d
Cleared Apr 14, 1987
DART THEOPHYLLINE REAGENT SYSTEM
K870736 · KLS
Coulter Electronics, Inc.
Toxicology · 48d
Cleared Apr 14, 1987
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
K870752 · CFJ
Miles Laboratories, Inc.
Chemistry · 48d
Cleared Apr 14, 1987
CHEMPRO 1000(TM)
K870860 · GKF
Arden Medical Systems, Inc.
Hematology · 42d
Cleared Apr 14, 1987
CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
K870864 · LLH
Marion Laboratories, Inc.
Microbiology · 42d
Cleared Apr 14, 1987
TOTAL IGE MASTICK
K870966 · DHB
Mast Immunosystems
Immunology · 35d
Cleared Apr 14, 1987
CHLAMYDIA & VIRAL TRANSPORT MEDIUM
K871065 · JSM
R. Kent Richards, Inc.
Microbiology · 27d
Cleared Apr 14, 1987
PROTECT T.M.
K871121 · JTR
Pro-Lab, Inc.
Microbiology · 26d
Cleared Apr 14, 1987
EMIT CARBAMAZEPINE ASSAY
K871306 · KLT
Syva Co.
Toxicology · 13d
Cleared Apr 14, 1987
DU PONT STERICELL CELL CULTURE SYSTEM
K871324 · KJA
E.I. Dupont DE Nemours & Co., Inc.
Pathology · 11d
Cleared Apr 14, 1987
MCBRIDE AGAR, MODIFIED
K871357 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 8d
Cleared Apr 13, 1987
NEUROCHEMICAL ANALYZER
K864729 · LEQ
Esa, Inc.
Chemistry · 130d
Cleared Apr 13, 1987
PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.
K870430 · FRO
Steridyne Laboratories, Inc.
General & Plastic Surgery · 69d
Cleared Apr 13, 1987
AFFINITY DIGOXIN IMMUNIT
K870552 · KXT
Bd Becton Dickinson Vacutainer...
Chemistry · 62d
Cleared Apr 13, 1987
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
K870737 · JJT
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 13, 1987
U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL
K870738 · JJT
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 13, 1987
ELITE ELECTROCARDIOGRAPH
K870920 · LOS
Burdick Corp.
Cardiovascular · 38d
Cleared Apr 13, 1987
SONAFON, THERAPEUTIC MASSAGER
K870972 · IRO
Electro Medica Office
Physical Medicine · 35d
Cleared Apr 13, 1987
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
K870986 · JIY
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Apr 13, 1987
OMEGA DORSAL COLUMELLA IMPLANTS
K871071 · FZE
Omega Silicone, Inc.
General & Plastic Surgery · 26d