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
151873–151896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1984
VON WILLEBRAND FACTOR ANTIGEN SCREEN
K842537 · ICF
American Dade
Hematology · 95d
Cleared Oct 01, 1984
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT
K842617 · GGP
American Dade
Hematology · 88d
Cleared Oct 01, 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654 · JHI
Beckman Instruments, Inc.
Immunology · 83d
Cleared Oct 01, 1984
ANTI-CHLAMYDIA TRACHOMATIS KIT
K842658 · LJP
Amico Lab, Inc.
Immunology · 83d
Cleared Oct 01, 1984
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · GKH
R&D Systems, Inc.
Hematology · 80d
Cleared Oct 01, 1984
FORMALIN BUFFERED
K842982 · IFP
Reagent Laboratory, Inc.
Pathology · 63d
Cleared Oct 01, 1984
TOOTH ROOT SOCKET GAUGE
K843154 · LYC
Interpore Intl.
Dental · 52d
Cleared Oct 01, 1984
BIOLAS YAG 100 CILAS, ERCELAS YAG 100
K843156 · LNK
Advanced Biomedical Instruments
Gastroenterology & Urology · 52d
Cleared Oct 01, 1984
EI-CANDIDA ENZYME IMMUNOASSAY EI1001
K843286 · LRF
Immuno-Mycologics, Inc.
Microbiology · 41d
Cleared Oct 01, 1984
WELLINGTON HOSPITAL PATTERN SELF-RETAIN
K843388 · HDF
Downs Surgical , Ltd.
Obstetrics & Gynecology · 33d
Cleared Oct 01, 1984
ENCORE IGE REAGENT
K843408 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Oct 01, 1984
BONE PLATES
K843553 · KTW
Mecron Medical Products, Inc.
Orthopedic · 21d
Cleared Oct 01, 1984
BONE SCREWS
K843554 · KTW
Mecron Medical Products, Inc.
Orthopedic · 21d
Cleared Oct 01, 1984
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · JWX
Difco Laboratories, Inc.
Microbiology · 21d
Cleared Oct 01, 1984
RIM-UREA
K843571 · JSS
Austin Biological Laboratories
Microbiology · 20d
Cleared Oct 01, 1984
FETAL BOVINE SERUM, F4884 STERILE GROWT
K843629 · KIS
Sigma Chemical Co.
Pathology · 17d
Cleared Oct 01, 1984
TOTAL PROTEIN REAGENT SET
K843701 · CEK
Livonia Diagnostics, Inc.
Chemistry · 10d
Cleared Sep 28, 1984
H.P.T. HOME PREG. TEST KIT & A.P.T.
K834474 · LCX
Biomedical Research & Development...
Chemistry · 283d
Cleared Sep 28, 1984
ISO-SEP SYSTEM
K842018 · CEX
Berwick Medical Products, Inc.
Chemistry · 133d
Cleared Sep 28, 1984
TITAN GEL ISO DOT CPK PROCEDURE
K842755 · CGS
Helena Laboratories
Chemistry · 74d
Cleared Sep 28, 1984
GLUCOSE AUTO& STAT GA-1120
K843003 · CGA
Kyoto Diagnostics, Inc.
Toxicology · 60d
Cleared Sep 28, 1984
ENZYMATIC CHOLESTEROL KIT
K843222 · CHH
Livonia Diagnostics, Inc.
Chemistry · 43d
Cleared Sep 28, 1984
CREATININE ASSAY KIT
K843377 · CGX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 28, 1984
VMA ASSAY KIT
K843379 · CDF
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d