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

Filters: Cleared only ×
176,076 results
167185–167208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1980
DEN-MAT POLISHING PASTE
K801225 · EJR
Den-Mat Corp.
Dental · 26d
Cleared Jun 17, 1980
HEARING AID, UNITRON MODEL C4-55
K801230 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 17, 1980
JACKSON LACRIMAL INTUBATION SET
K801232 · HNL
Storz Instrument Co.
Ophthalmic · 21d
Cleared Jun 17, 1980
HYDRA TRED DC
K801250 · IOG
Medichanics, Inc.
Physical Medicine · 20d
Cleared Jun 17, 1980
TECNOL QUICK RELEASE LIMB HOLDER
K801272 · FMQ
Tecnol New Jersey Wound Care, Inc.
General Hospital · 20d
Cleared Jun 17, 1980
ACOUSTIC IMPEDANCE METER, MODEL TA-4D
K801293 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 15d
Cleared Jun 17, 1980
CAMLOC SYRINGE BIOPSY KIT
K801304 · GEE
Johannah Medical Services, Inc.
General & Plastic Surgery · 9d
Cleared Jun 17, 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · FMF
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Jun 17, 1980
THE PROTECTORS
K801312
Cooper Medical Devices Corp.
General & Plastic Surgery · 14d
Cleared Jun 17, 1980
AO STYLET LARYNGOSCOPE MODEL SLS
K801364 · CAL
American Optical Corp.
Anesthesiology · 7d
Cleared Jun 17, 1980
ECA CREAM REFORMULATION
K801383 · GYB
Vanaray Laboratories, Inc.
Neurology · 6d
Cleared Jun 09, 1980
BUN-COLOR 2, BLOOD UREA NITROGEN TEST
K800902 · CDL
Sclavo, Inc.
Chemistry · 52d
Cleared Jun 09, 1980
J.T. BAKER LSA 290 PIPETTER/DILUTER
K801090 · JQW
J.T. Baker Chemical Co.
Chemistry · 32d
Cleared Jun 09, 1980
K 750 COMPUTER/DATA PROCESSOR
K801091 · JQP
J.T. Baker Chemical Co.
Chemistry · 32d
Cleared Jun 09, 1980
SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL
K801094 · KWH
Dow Corning Corp. Healthcare...
Orthopedic · 32d
Cleared Jun 09, 1980
PERKIN ELMER MODEL 91 AMYLASE REAGENT
K801096 · KHM
Stat Engineering
Chemistry · 31d
Cleared Jun 09, 1980
THYROXINE RADIOIMMUNOASSAY KIT
K801105 · CDX
Calbiochem-Behring Corp.
Chemistry · 31d
Cleared Jun 09, 1980
COBAS TOTAL BILIRUBIN REAGENT & DILUENT
K801117 · CIG
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 09, 1980
COBAS REAGENT FOR ALT (GPT)
K801119 · CKA
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 09, 1980
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM
K801123 · CDP
Calbiochem-Behring Corp.
Chemistry · 28d
Cleared Jun 09, 1980
SPAC T3 RIA TEST KIT
K801125 · CDP
Mallinckrodt Critical Care
Chemistry · 28d
Cleared Jun 09, 1980
CENTRIFICHEM SYSTEM 500 ANALYZER
K801139 · JJG
Union Carbide Corp.
Chemistry · 27d
Cleared Jun 09, 1980
ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS
K801144 · FHT
Ethox Corp.
Gastroenterology & Urology · 27d
Cleared Jun 09, 1980
SMI MULTI-TUBE VORTEXER
K801145 · JRQ
Scientific Manufacturing Industries
Chemistry · 27d