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
139393–139416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1987
NON-WOVEN TRACHEOTOMY SPONGE
K872807 · GDY
American Silk Sutures, Inc.
General & Plastic Surgery · 21d
Cleared Aug 04, 1987
CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8
K872808 · EFQ
American Silk Sutures, Inc.
General & Plastic Surgery · 21d
Cleared Aug 04, 1987
GAUZE CHERRY SPONGE
K872809 · GDY
American Silk Sutures, Inc.
General & Plastic Surgery · 21d
Cleared Aug 04, 1987
FOLDING WHEELCHAIR
K872940 · IOR
Health Care Innovations, Inc.
Physical Medicine · 8d
Cleared Aug 03, 1987
BAG-TAIL BLEED VALVE
K870859 · CAI
Dryden Corp.
Anesthesiology · 153d
Cleared Aug 03, 1987
ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE
K871441 · DRX
Nitto Denko America, Inc.
Cardiovascular · 112d
Cleared Aug 03, 1987
CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS
K871774 · DTR
Gish Biomedical, Inc.
Cardiovascular · 89d
Cleared Aug 03, 1987
WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY
K871776 · JWH
Dow Corning Wright
Orthopedic · 89d
Cleared Aug 03, 1987
STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM
K871816 · EAY
Stryker Corp.
Dental · 84d
Cleared Aug 03, 1987
ARGYLE VASCULAR BYPASS SET
K871844 · DWF
Sherwood Medical Co.
Cardiovascular · 87d
Cleared Aug 03, 1987
STOM-VENT
K872153 · BYD
Gibeck Respiration
Anesthesiology · 60d
Cleared Aug 03, 1987
MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH
K872154 · DQT
Ideas For Medicine, Inc.
Cardiovascular · 63d
Cleared Aug 03, 1987
ORAL SUCTION CATHETER
K872283 · BSY
Ballard Medical Products
Anesthesiology · 48d
Cleared Aug 03, 1987
DEVO/MC44 OXYGEN CONCENTRATOR
K872470 · CAW
The Devilbiss Co.
Anesthesiology · 87d
Cleared Aug 03, 1987
STERILIZED OMNI GEL
K872519 · JOT
Echo Ultrasound
General & Plastic Surgery · 39d
Cleared Aug 03, 1987
HEARING-AID
K872552 · ESD
Audio-Technica U.S., Inc.
Ear, Nose, Throat · 35d
Cleared Aug 03, 1987
MICROMI-CK(TM)
K872598 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 32d
Cleared Aug 03, 1987
SYNERGY
K872890 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 11d
Cleared Aug 03, 1987
DENTIN ADHESIVE
K872907 · EBF
Dentsply Intl.
Dental · 10d
Cleared Jul 31, 1987
SCALP VEIN SET
K870995 · FPA
Mac Lee Medical Products
General Hospital · 142d
Cleared Jul 31, 1987
GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)
K871146 · JWH
Richards Medical Co., Inc.
Orthopedic · 130d
Cleared Jul 31, 1987
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY
K871746 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 87d
Cleared Jul 31, 1987
DRILL, HAND, BONE, SMEDBERG
K871834 · DZJ
Military Engineering, Inc.
Dental · 80d
Cleared Jul 31, 1987
ANCHOR IIA/2 STAGE OSSEO. TIT. 6/4 ALLOY IMPLANT
K871887 · DZE
Anchor Implants , Ltd.
Dental · 78d