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
157057–157080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1983
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742 · CGJ
Bio-Rad
Chemistry · 48d
Cleared Jul 18, 1983
LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-
K831774 · DGO
Diagnostic Reagent Tech.
Immunology · 46d
Cleared Jul 18, 1983
PLASTIC DISPOSABLE RAZOR
K831799 · LDQ
I M, Inc.
General & Plastic Surgery · 45d
Cleared Jul 18, 1983
CATHETER INSERTION TRAYS, VARIOUS #'S
K831807 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 42d
Cleared Jul 18, 1983
ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY
K831826 · CKG
Damon Corp.
Microbiology · 41d
Cleared Jul 18, 1983
STAINLESS STEEL GUIDE WIRE
K831839 · DQX
Quinton, Inc.
Cardiovascular · 41d
Cleared Jul 18, 1983
GILCHEM TOTAL BILIRUBIN REAGENT
K831843 · CIG
Gilford Diagnostics
Chemistry · 40d
Cleared Jul 18, 1983
DIRECT BILIRUBIN REAGENT
K831844 · CIG
Gilford Diagnostics
Chemistry · 40d
Cleared Jul 18, 1983
CALIBRATOR 282
K831872 · KRZ
Bionostics, Inc.
Hematology · 35d
Cleared Jul 18, 1983
FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
K831902 · DDZ
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBITT ANTISERUM TO HUMAN C3C
K831905 · CZW
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBIT ANTISERUM TO HUMAN IGG
K831908 · DGK
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBIT ANTISERUM TO HUMAN IGA
K831909 · CZN
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
ANTINUCLEAR ANTIBODY TEST KIT
K831927 · DAA
Breit Laboratories, Inc.
Immunology · 33d
Cleared Jul 18, 1983
LEAP RHEUMATOID FACTOR TEST KIT
K831941 · DHR
Cooper Diagnostics, Inc.
Immunology · 32d
Cleared Jul 18, 1983
DETERM. SIZE 72 RADIAL-HUMAN IGD
K831956 · CZJ
Kent Laboratories, Inc.
Chemistry · 31d
Cleared Jul 18, 1983
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
K831957 · DAD
Kent Laboratories, Inc.
Chemistry · 31d
Cleared Jul 18, 1983
VIVONEX TUNGSTEN TIP TUBE-MONOFILA-
K831970 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 18, 1983
STOMACH TUBE LEVIN TUBE
K831974 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 18, 1983
MODEL #27224P CONTINUOUS FLOW PUMP
K832009 · OCX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 18, 1983
CERTAIN HB CO-OXIMETER CONTROL
K832028 · JJS
Corning Medical & Scientific
Hematology · 25d
Cleared Jul 18, 1983
QEA SODIUM/POTASSIUM ANALYZER
K832036 · CEM
Bd Becton Dickinson Vacutainer...
Chemistry · 24d
Cleared Jul 18, 1983
CELL-DYN 300 HEMATOLOGY ANALYZER
K832038 · GKL
Abbott Diagnostics
Hematology · 24d
Cleared Jul 18, 1983
EXTERNAL INCONTINENCE CATHETER SET-NON
K832108 · KNX
Plasco, Inc.
Gastroenterology & Urology · 19d