FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79681–79704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · HRX
Ebi, L.P.
Orthopedic · 21d
Cleared Feb 09, 2001
JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
K010231 · LYY
Jk Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Feb 09, 2001
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
K010282 · LPH
Stelkast Company
Orthopedic · 10d
Cleared Feb 09, 2001
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
K993856 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 452d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · LOD
Exactech, Inc.
Orthopedic · 322d
Cleared Feb 08, 2001
ORG-9200A
K002068 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 216d
Cleared Feb 08, 2001
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
K002712 · FLL
Saat , Ltd.
General Hospital · 161d
Cleared Feb 08, 2001
CANNULATED SCREW SYSTEM
K003496 · HTN
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 08, 2001
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
K003512 · HQC
A.R.C. Laser AG
Ophthalmic · 86d
Cleared Feb 08, 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · DRB
Medtronic Vascular
Cardiovascular · 84d
Cleared Feb 08, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
K003586 · MVN
Ciba-Geigy Corp.
Ophthalmic · 80d
Cleared Feb 08, 2001
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
K003627 · FMI
Exelint International, Co.
General Hospital · 76d
Cleared Feb 08, 2001
BIOLOK SCREW, BIOSTEON SCREW
K003641 · HWC
Biocomposites, Ltd.
Orthopedic · 73d
Cleared Feb 08, 2001
TAPER-FIT TOTAL HIP SYSTEM
K003666 · JDI
Corin USA
Orthopedic · 72d
Cleared Feb 08, 2001
ENVIVE MINIFORMS
K003843 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 58d
Cleared Feb 08, 2001
2010 PLUS HOLTER FOR WINDOWS
K003940 · MLO
Agilent Technologies
Cardiovascular · 49d
Cleared Feb 08, 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · ESW
Rusch Intl.
Gastroenterology & Urology · 31d
Cleared Feb 08, 2001
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
K010190 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 17d
Cleared Feb 08, 2001
PROTRACT PRESS FIT HIP STEM-HA COATED
K010241 · LPH
Stelkast Company
Orthopedic · 14d
Cleared Feb 07, 2001
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
K000776 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 334d
Cleared Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 180d
Cleared Feb 07, 2001
HOLY DRAGON ACUPUNCTURE NEEDLES
K002910 · MQX
Anc Import & Export Co. , Ltd.
General Hospital · 142d
Cleared Feb 07, 2001
ULTRASOUND SCANNER TYPE 2101
K003041 · IYO
B & K Medical A/S
Radiology · 131d
Cleared Feb 07, 2001
BIO-EYE II ORBITAL IMPLANT
K003338 · HPZ
Integrated Orbital Implants, Inc.
Ophthalmic · 105d