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
147721–147744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1985
TECA TC2-64 TRANSCRANIAL DOPPLER
K850137 · DPW
Teca, Inc.
Cardiovascular · 212d
Cleared Aug 14, 1985
COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY
K851000 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 156d
Cleared Aug 14, 1985
KITECKO ULTRASOUND STANDOFF PAD
K851982 · IYO
3M Company
Radiology · 99d
Cleared Aug 14, 1985
SONORANGER
K852549 · IYO
Ausonics Pty , Ltd.
Radiology · 58d
Cleared Aug 14, 1985
GASTRO-ENTEROSTOMY TUBE
K852707 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 49d
Cleared Aug 14, 1985
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
K852827 · GZB
Cordis Corp.
Neurology · 43d
Cleared Aug 13, 1985
THE FEVER-THERM A THERM. MEASURING DEVICE
K850395 · FLL
Kma, Inc.
General Hospital · 193d
Cleared Aug 13, 1985
URINE DUO
K851225 · JTZ
Culture Kits, Inc.
Microbiology · 140d
Cleared Aug 13, 1985
BRANDT TRACHEAL TUBE(TENTATIVE)
K852025 · BTR
Mallinckrodt Critical Care
Anesthesiology · 97d
Cleared Aug 13, 1985
ENDOPORT 5MM
K852031 · HET
Endotherapeutics
Obstetrics & Gynecology · 96d
Cleared Aug 13, 1985
SIERRA -OXYGEN CONCENTRATE
K852144 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 89d
Cleared Aug 13, 1985
BELIEVE DEODORANT LABIAL PADS
K852225 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 83d
Cleared Aug 13, 1985
#6010 NON-CONDUCTIVE VENTILATOR CIRCUIT
K852314 · CAI
Sigma Medical, Inc.
Anesthesiology · 76d
Cleared Aug 13, 1985
COAGULATOR
K852492 · KQG
Med USA
Hematology · 62d
Cleared Aug 13, 1985
OXYMATICTM ELECTRONIC OXGYEN CONSERVER
K852650 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 53d
Cleared Aug 13, 1985
SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
K852665 · JWZ
Syncor Intl. Corp.
Microbiology · 50d
Cleared Aug 13, 1985
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
K852705 · JDI
Waldemar Link GmbH & Co. KG
Orthopedic · 48d
Cleared Aug 13, 1985
GENERAL DIAGNOSTICS COAG-A-MATE XC
K852843 · KQC
Warner-Lambert Co.
Hematology · 39d
Cleared Aug 13, 1985
S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM
K853005 · EGZ
The S. S. White Co.
Dental · 28d
Cleared Aug 13, 1985
AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
K853081 · KJK
Advanced Medical Technology, Inc.
Pathology · 21d
Cleared Aug 13, 1985
ECUMOL ULTRAVIOLET SUNTANNNING BEDS
K853177 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 14d
Cleared Aug 13, 1985
PIGGYMATE I.V. TUBING LOCK
K853184 · FPA
Trend Medical, Inc.
General Hospital · 14d
Cleared Aug 13, 1985
ACRIDINE ORANGE FLUORESCENT STAIN
K853187 · IDC
Advanced Medical Technology, Inc.
Pathology · 14d
Cleared Aug 13, 1985
CALCIUM CHLORIDE
K853246 · JPA
Bio/Data Corp.
Hematology · 12d