FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78265–78288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · FGE
Cordis Corp.
Gastroenterology & Urology · 196d
Cleared Aug 27, 2001
NEUROEDGE INFUSION CATHETER
K011646 · KRA
Neuro Vasx, Inc.
Cardiovascular · 90d
Cleared Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Aug 27, 2001
GPW-SF
K011659 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
CONCORD 88
K011661 · EJT
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
MACROPORE IB RESORBABLE PLUG
K011715 · JDI
Macropore Biosurgery, Inc.
Orthopedic · 84d
Cleared Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...
K011886 · ODG
Olympus America, Inc.
Radiology · 73d
Cleared Aug 27, 2001
DIRECT BILIRUBIN REAGENT
K011972 · CIG
Intersect Systems, Inc.
Chemistry · 63d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109 · DLJ
Microgenics Corp.
Toxicology · 52d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · DKZ
Microgenics Corp.
Toxicology · 52d
Cleared Aug 27, 2001
ERIS LAYERING MATERIALS
K012174 · EIH
Ivoclar North America, Inc.
Dental · 46d
Cleared Aug 27, 2001
CLAY-PARK LABS, INC. - LUBRICATING JELLY
K012203 · NUC
Clay-Park Labs, Inc.
Obstetrics & Gynecology · 45d
Cleared Aug 27, 2001
TAO EMBRYO TRANSFER CATHETER SYSTEM
K012220 · MQF
Ttj Biomedical, LLC
Obstetrics & Gynecology · 42d
Cleared Aug 27, 2001
POINT 4 FLOWABLE
K012321 · EBF
Sybron Dental Specialties, Inc.
Dental · 35d
Cleared Aug 27, 2001
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
K012430 · JJX
Bionostics, Inc.
Chemistry · 27d
Cleared Aug 27, 2001
TERUMO 30 GAUGE HYPODERMIC NEEDLE
K012646 · FMI
Terumo Medical Corp.
General Hospital · 14d
Cleared Aug 27, 2001
EZ SET INFUSION SET
K012754 · FPA
Animas Corp.
General Hospital · 11d
Cleared Aug 24, 2001
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
K002339 · IPF
Apex Medical Corp.
Physical Medicine · 388d
Cleared Aug 24, 2001
MAVIDON MEDICAL ELECTRODE JELLY
K003924 · GYB
Mavidon Medical Products
Neurology · 247d
Cleared Aug 24, 2001
FORTAFLEX SURGICAL MESH
K011025 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 141d
Cleared Aug 24, 2001
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT...
K011072 · LPL
Gelflex
Ophthalmic · 137d
Cleared Aug 24, 2001
HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
K011744 · ITI
Transworld Mobility Distribution, LLC
Physical Medicine · 80d
Cleared Aug 24, 2001
MB 11
K011746 · GWJ
Maico Diagnostic GmbH
Neurology · 79d
Cleared Aug 24, 2001
THE SPIN SNAP-OFF SCREW
K011946 · HWC
New Deal, S.A.
Orthopedic · 64d