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
42529–42552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2012
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT...
K122937 · DQO
Cook, Inc.
Cardiovascular · 81d
Cleared Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · NBW
ACON Laboratories, Inc.
Chemistry · 78d
Cleared Dec 14, 2012
CATHETER CONNECTIONS DUALCAP SOLO
K123065 · QBP
Catheter Connections, Inc.
General Hospital · 74d
Cleared Dec 14, 2012
MAXLOCK EXTREME SYSTEM MODEL MXL
K123203 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 63d
Cleared Dec 14, 2012
EMVERA DIOLUX
K123257 · GEX
Emvera Technologies, Inc.
General & Plastic Surgery · 57d
Cleared Dec 14, 2012
GYRUS ACMI BICOAG HEMOSTASIS PROBE
K123319 · KNS
Olympus Surgical Technologies America
Gastroenterology & Urology · 49d
Cleared Dec 14, 2012
MEDILAS H LASER FIBERS
K123385 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 42d
Cleared Dec 14, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K123531 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 28d
Cleared Dec 14, 2012
OCELOT PIXL CATHETER
K123532 · PDU
Avinger, Inc.
Cardiovascular · 28d
Cleared Dec 13, 2012
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
K113771 · FAP
Neurovision Medical Products, Inc.
Gastroenterology & Urology · 357d
Cleared Dec 13, 2012
MEDLINX SURGICAL MESH
K120844 · FTL
Medlinx Acala Pte, Ltd.
General & Plastic Surgery · 268d
Cleared Dec 13, 2012
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS...
K120936 · DKB
Microgenics Corporation
Toxicology · 260d
Cleared Dec 13, 2012
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM...
K121218 · QPB
Andrew Technologies, LLC
General & Plastic Surgery · 234d
Cleared Dec 13, 2012
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
K121398 · DQX
Guidepath Medical, Inc.
Cardiovascular · 218d
Cleared Dec 13, 2012
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K121853 · MKJ
Defibtech, LLC
Cardiovascular · 171d
Cleared Dec 13, 2012
ENAMIC
K122269 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 136d
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT...
K122459 · OTP
Boston Scientific Corporation
Obstetrics & Gynecology · 122d
Cleared Dec 13, 2012
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535 · EOQ
Fujifilm Medical System U.S.A., Inc.
Ear, Nose, Throat · 115d
Cleared Dec 13, 2012
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
K122613 · LNH
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Dec 13, 2012
CELLTRACKS AUTOPREP SYSTEM
K122821 · NQI
Veridex, LLC
Pathology · 90d
Cleared Dec 13, 2012
ZOLL SUREPOWER SINGLE BAY CHARGER
K122839 · MKJ
ZOLL Medical Corporation
Cardiovascular · 87d
Cleared Dec 13, 2012
MILAGRO INTERFERENCE SCREWS
K122869 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 85d
Cleared Dec 13, 2012
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K122958 · DYB
Oscor, Inc.
Cardiovascular · 79d
Cleared Dec 13, 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K122960 · DYB
Oscor, Inc.
Cardiovascular · 79d