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
163345–163368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1981
UROFLOWMETER
K811925 · FFG
C.R. Bard, Inc.
Gastroenterology & Urology · 68d
Cleared Sep 08, 1981
J & S IRON SATURATING REAGENT
K811942 · JQF
Thyroid Diagnostics, Inc.
Toxicology · 63d
Cleared Sep 08, 1981
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
K812006 · LHL
Centers For Disease Control and...
Microbiology · 54d
Cleared Sep 08, 1981
LEGIONELLA INDIRECT FLUOR. ANTIBODY
K812007 · LHL
Centers For Disease Control and...
Microbiology · 54d
Cleared Sep 08, 1981
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · HQG
American Optical Corp.
Ophthalmic · 49d
Cleared Sep 08, 1981
PROPOSED CONTROLS FOR DOSIMETRIC RELEASE
K812068 · LIB
Hexcel Medical
Microbiology · 49d
Cleared Sep 08, 1981
GINGI-PLAIN CORDS & BRAIDS
K812120 · JES
Belport Co., Inc.
Dental · 43d
Cleared Sep 08, 1981
VISIO-FIL
K812169 · EBF
Espe GmbH (Us)
Chemistry · 40d
Cleared Sep 08, 1981
CASTLE TEC-TEST BIOLOGICAL INDICATOR
K812272 · FRC
Sybron Corp.
General Hospital · 26d
Cleared Sep 08, 1981
PRISMA-FIL COMPULES
K812277 · EID
Caulk Co., Div. Dentsply
Dental · 26d
Cleared Sep 08, 1981
ZEE ELECTRODE-GEL
K812284 · GYB
Zee Medical Products Co., Inc.
Neurology · 26d
Cleared Sep 08, 1981
SHILEY FENESTRATED LOW PRESS. CUFFED
K812302 · JOH
Shiley, Inc.
Anesthesiology · 25d
Cleared Sep 08, 1981
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE
K812305 · KCF
Boston Medical Products, Inc.
Ear, Nose, Throat · 22d
Cleared Sep 08, 1981
SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT
K812328 · DEW
Scripps-Miles, Inc.
Immunology · 21d
Cleared Sep 08, 1981
CYCLES REUSABLE MENSTRUAL PADS
K812333 · HHD
Cycles
Obstetrics & Gynecology · 21d
Cleared Sep 08, 1981
GUINEA PIG COMPLEMENT VIRUS ANTIBODY
K812369 · KTQ
Dutchland Laboratories, Inc.
Immunology · 19d
Cleared Sep 08, 1981
GUINEA PIG COMPLEMENT REGULAR
K812370 · KTQ
Dutchland Laboratories, Inc.
Immunology · 19d
Cleared Sep 08, 1981
HEMOLYSIN
K812371
Dutchland Laboratories, Inc.
Immunology · 19d
Cleared Sep 08, 1981
GUINEA PIG SERUM - STERILE
K812379 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
RABBIT SERUM - STERILE
K812380 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR HORSE SERUM - STERILE
K812381 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR CALF (BOVINE-SERUM) - STERILE
K812382 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
CALF (BOVINE) SERUM - STERILE
K812383 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
NEWBORN CALF SERUM - STERILE
K812384 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d