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
77761–77784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 24, 2001
DISPOSABLE VITRECTOMY LENS
K012096 · HJK
Ocular Instruments, Inc.
Ophthalmic · 50d
Cleared Aug 24, 2001
FLEX-NAILS
K012161 · HTY
Fixano SA
Orthopedic · 44d
Cleared Aug 24, 2001
ULTRACELL ABSORBENT STICK
K012196 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 42d
Cleared Aug 24, 2001
QUIK-CHECK OVULATION PREDICTOR
K012252 · CEP
ACON Laboratories, Inc.
Chemistry · 37d
Cleared Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · DIF
Randox Laboratories, Ltd.
Chemistry · 32d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 24, 2001
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
K012445 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 23d
Cleared Aug 23, 2001
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
K010772 · JAA
Imaging Services, Inc.
Radiology · 162d