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
140929–140952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1987
ALANINE TRANSAMINASE (ALT) TEST KIT
K870879 · CKA
Genetic Systems Corp.
Chemistry · 15d
Cleared Mar 19, 1987
STEADY RESIN
K870908 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 14d
Cleared Mar 19, 1987
COAT-A-COUNT METHAQUALONE TKMQ1
K870935 · KXS
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5
K870936 · DIS
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
COAT-A-COUNT METHADONE TKMD1
K870937 · DJR
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
RICHARDS EXTERNAL FIXATION SYSTEM
K870961 · KTT
Richards Medical Co., Inc.
Orthopedic · 9d
Cleared Mar 19, 1987
T-TUBE INSERTER
K870978 · JYM
Sur-Med Instruments, Inc.
Ear, Nose, Throat · 9d
Cleared Mar 19, 1987
SEWON DENTAL FLOSSER
K870996 · JES
Sewon Industry
Dental · 8d
Cleared Mar 18, 1987
THE EXPERIMENTAL
K864455 · EFW
Martin H. Kaufmann
Dental · 126d
Cleared Mar 18, 1987
BONDEX* GLASS IONOMER CEMENT
K870211 · EMA
Johnson & Johnson Professionals, Inc.
Dental · 57d
Cleared Mar 18, 1987
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK
K870374 · DYB
Daig Corp.
Cardiovascular · 48d
Cleared Mar 18, 1987
AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY
K870397 · GEI
Sunkey Medical Manufacturing, Inc.
General & Plastic Surgery · 44d
Cleared Mar 18, 1987
O.B. SLENDER REGULAR TAMPON
K870539 · HEB
Personal Products Co.
Obstetrics & Gynecology · 37d
Cleared Mar 18, 1987
BUR BRUSH
K870760
Treace Medical, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 1987
SUPER SCISSORS
K870763
Treace Medical, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 1987
SCHUKNECHT WIRE CUTTING SCISSORS
K870764
Treace Medical, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 1987
TRU-STIM MUSCLE STIMULATOR
K870774 · IPF
Briefcase, Inc.
Physical Medicine · 20d
Cleared Mar 18, 1987
A.T.S. 1500 TOURNIQUET
K870784 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 1987
NOTCH-NEEDLE, WESCOTT STYLE
K870896 · GAA
Ocean Medical Products, Ltd.
General & Plastic Surgery · 13d
Cleared Mar 18, 1987
ULTRA-LUX LIGHT SOURCE
K870898 · FSW
Medline Industries, Inc.
General & Plastic Surgery · 13d
Cleared Mar 17, 1987
DIAMOND MEDICAL, INC., MODEL DM 700
K863298 · FFT
Diamond Medical, Inc.
Gastroenterology & Urology · 204d
Cleared Mar 17, 1987
BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010
K863833 · DSB
Body Watch, Inc.
Cardiovascular · 168d
Cleared Mar 17, 1987
VETA/VENTED ESOPHAGEAL TUBE AIRWAY
K864200 · CAO
Cranco Co.
Anesthesiology · 141d
Cleared Mar 17, 1987
HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI
K864265 · KPO
Dial Medical of Florida, Inc.
Gastroenterology & Urology · 139d