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
149497–149520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1985
CERESTORE DENTIN PORCELAIN
K850821 · EIH
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Apr 08, 1985
PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST
K850824 · EBF
Kuraray Co.
Dental · 39d
Cleared Apr 08, 1985
STREP A QUICK
K850831 · GTZ
Abbott Laboratories
Microbiology · 38d
Cleared Apr 08, 1985
DATA ZYME CO2 PROCEDURE
K850903 · KHS
Data Medical Associates, Inc.
Chemistry · 34d
Cleared Apr 08, 1985
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
K850987 · JHI
Medix Biotech, Inc.
Chemistry · 28d
Cleared Apr 08, 1985
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
K850999 · JJF
Technicon Instruments Corp.
Chemistry · 28d
Cleared Apr 08, 1985
GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.
K851110 · HFB
The Huxley Instrument Corp.
Obstetrics & Gynecology · 20d
Cleared Apr 08, 1985
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
K851207 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 13d
Cleared Apr 08, 1985
COMPACT EXCHANGE DEVICE 5C4197
K851208 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 13d
Cleared Apr 05, 1985
AUDIT TM V
K843712 · GWF
Axonics, Inc.
Neurology · 196d
Cleared Apr 05, 1985
CYBERTENS
K844680 · GZJ
Pori Associates, Inc.
Neurology · 126d
Cleared Apr 05, 1985
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
K850181 · LBI
Aequitron Medical, Inc.
General Hospital · 77d
Cleared Apr 05, 1985
AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE
K850265 · CAH
American Pharmaseal Div. Ahsc
General Hospital · 72d
Cleared Apr 05, 1985
TEMPALERT LIQUID CRYSTAL THERMOMETER
K850797 · KPD
Medical Frontiers, Inc.
General Hospital · 37d
Cleared Apr 05, 1985
EMIT QST N-ACETYLPROCAINAMIDE ASSAY
K851060 · LAN
Syva Co.
Toxicology · 21d
Cleared Apr 04, 1985
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K844214 · LXC
Stryker Corp.
Orthopedic · 155d
Cleared Apr 04, 1985
KONTRON MINIMON 7134 PATIENT MONITOR
K844215 · DRT
Kontron Instruments, Inc.
Cardiovascular · 155d
Cleared Apr 04, 1985
MATRIX 101 NEGATIVE GALVANIC GENERATOR
K844816 · GEI
Prn Medical
General & Plastic Surgery · 114d
Cleared Apr 04, 1985
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
K844988 · DXQ
Ethox Corp.
Cardiovascular · 99d
Cleared Apr 04, 1985
MEDITECH EUROSCANNER M250
K850027 · JAK
Stuart Medical, Inc.
Radiology · 90d
Cleared Apr 04, 1985
TREADMILL E-17
K850044 · IOL
Del Mar Avionics
Physical Medicine · 87d
Cleared Apr 04, 1985
WHEELCHAIR, MECHANICAL
K850064 · IOR
Comaco, Inc.
Physical Medicine · 86d
Cleared Apr 04, 1985
HAND HELD GONIOMETER
K850082 · KQW
Chattanooga Group, Inc.
Neurology · 84d
Cleared Apr 04, 1985
CLINICAL ELECTRONIC THERMOMETERS
K850244 · FLL
Sheridan Catheter Corp.
General Hospital · 72d