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
169945–169968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1979
ABUSCREEN RIA FOR PHENCYCLIDINE
K790655 · LCL
Hoffmann-La Roche, Inc.
Toxicology · 71d
Cleared Jun 15, 1979
PROPHYLAXIS ANGLE
K790722 · EGS
Young Dental Manufacturing Co. 1, LLC
Dental · 66d
Cleared Jun 15, 1979
PROPHYLAXIS CUPS AND POLISHERS
K790723 · EHK
Young Dental Manufacturing Co. 1, LLC
Dental · 66d
Cleared Jun 15, 1979
PREGNOSTICON PREGNANCY TEST KIT
K790734 · JHJ
Organon, Inc.
Chemistry · 60d
Cleared Jun 15, 1979
CHEMTAB
K790772 · JIM
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jun 15, 1979
ENZYMATIC TRIGLYCERIDES-S.V.R.
K790773 · CDT
Calbiochem-Behring Corp.
Chemistry · 56d
Cleared Jun 15, 1979
GLUCOSE (HK) REAGENT
K790786 · CFR
Gilford Diagnostics
Chemistry · 53d
Cleared Jun 15, 1979
ELECTROPHORESIS REAGENT SET, HDL
K790791 · LBT
Gelman Sciences, Inc.
Chemistry · 52d
Cleared Jun 15, 1979
CENTRIA T4 RIA TEST SET
K790800 · CDX
Ventrex Laboratories, Inc.
Toxicology · 52d
Cleared Jun 15, 1979
ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST
K790831 · GTQ
Icl Scientific
Microbiology · 46d
Cleared Jun 15, 1979
14 KARAT CASTING GOLD
K790866 · EJT
Williams Gold Refining Co., Inc.
Dental · 39d
Cleared Jun 15, 1979
QUAD IV CUSTOM IMPRESSION TRAY
K790897 · EBH
Sted, Inc.
Dental · 37d
Cleared Jun 15, 1979
NUCLEAR SAMPLE READER
K790905 · JJJ
Abbott Laboratories
Toxicology · 35d
Cleared Jun 15, 1979
EMIT AUTO DIGOXIN ASSAY
K790937 · KXT
Syva Co.
Toxicology · 28d
Cleared Jun 15, 1979
HISTO-OILER
K790956 · JTC
Dynatech Laboratories, Inc.
Microbiology · 24d
Cleared Jun 15, 1979
HISTO-DISPENSER
K790957 · JTC
Dynatech Laboratories, Inc.
Microbiology · 24d
Cleared Jun 15, 1979
LO-ION
K790973 · KSG
Gamma Biologicals, Inc.
Hematology · 23d
Cleared Jun 15, 1979
MUSCLE TESTING GUN
K791021 · HRW
The Orthodyn Co.
Neurology · 16d
Cleared Jun 15, 1979
CARDIAC CATHETERIZATION SHEETS/PACKS
K791032 · KKX
Surgikos, Inc.
General Hospital · 11d
Cleared Jun 15, 1979
PIGGYBACK BREATHING CIRCUIT
K791034 · BZO
Vital Signs, Inc.
Anesthesiology · 10d
Cleared Jun 15, 1979
CENTRIA T3 UPTAKE TEST SET
K791050
Ventrex Laboratories, Inc.
Toxicology · 9d
Cleared Jun 15, 1979
RAIN-X
K791060 · BZO
Sherwood Medical Co.
Anesthesiology · 7d
Cleared Jun 15, 1979
LIBCO 1,2,3, EYEGLASS FRAMES
K791112 · HQZ
Libco Eyewear, Inc.
Ophthalmic
Cleared Jun 13, 1979
FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
K790464 · GLZ
Intl. Diagnostic Technology
Microbiology · 100d