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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
78889–78912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 23, 2001
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
K010918 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 149d
Cleared Aug 23, 2001
STRAUMANN GBR SYSTEM
K011698 · JEY
Institut Straumann AG
Dental · 83d
Cleared Aug 23, 2001
RADIUS NEXT GENERATION GUIDEWIRE
K011759 · OCY
Radius Medical Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 23, 2001
HI-WAVE
K011762 · EBI
Denplus, Inc.
Dental · 77d
Cleared Aug 23, 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231 · EIH
Jeneric/Pentron, Inc.
Dental · 38d
Cleared Aug 23, 2001
LUXACORE/LUXACORE DUAL
K012307 · EBF
Dmg USA, Inc.
Dental · 31d
Cleared Aug 23, 2001
PERMACEM / PERMACEM DUAL
K012316 · EMA
Dmg USA, Inc.
Dental · 31d