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
72673–72696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2003
MICROFIX QUICKANCHOR PLUS
K024115 · HWC
Mitek Worldwide
Orthopedic · 90d
Cleared Mar 13, 2003
EXPRESS MINI GLAUCOMA SHUNT
K030350 · KYF
Optonol, Ltd.
Ophthalmic · 38d
Cleared Mar 13, 2003
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
K030455 · IYN
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Mar 13, 2003
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES...
K030566 · JJY
Cliniqa Corporation
Chemistry · 17d
Cleared Mar 12, 2003
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
K022004 · DQO
Biosensors International-USA
Cardiovascular · 266d
Cleared Mar 12, 2003
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
K023693 · FRF
Airex, Inc.
General Hospital · 131d
Cleared Mar 12, 2003
OPTIMA, SPINAL SYSTEM
K024096 · MNI
U&I Corp., America
Orthopedic · 90d
Cleared Mar 12, 2003
HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
K024138 · GEI
Olympus Optical Co., Ltd.
General & Plastic Surgery · 86d
Cleared Mar 12, 2003
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
K024201 · HAW
Image-Guided Neurologics, Inc.
Neurology · 82d
Cleared Mar 12, 2003
KAVO EVEREST TITANBLANK
K024214 · EJH
Kavo America
Dental · 82d
Cleared Mar 12, 2003
MSI TA ELECTRODES
K024266 · GEI
Medsphere International, Inc.
General & Plastic Surgery · 79d
Cleared Mar 12, 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024335 · GEX
Candela Corp.
General & Plastic Surgery · 75d
Cleared Mar 12, 2003
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
K030036 · DYH
Pulpdent Corporation
Dental · 68d
Cleared Mar 12, 2003
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL...
K030038 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 65d
Cleared Mar 12, 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · KXK
Varian Medical Systems
Radiology · 2d
Cleared Mar 11, 2003
OPTIDOS
K010705 · KXK
Ptw-New York Corp.
Radiology · 732d
Cleared Mar 11, 2003
IMBIBE BONE MARROW ASPIRATION SYRINGE
K023074 · FMF
Orthovita, Inc.
General Hospital · 176d
Cleared Mar 11, 2003
TRACERS BONE CEMENT OPACIFIER
K023445 · MYU
Parallax Medical, Inc.
Neurology · 147d
Cleared Mar 11, 2003
OSSE-LIGN
K023564 · JDQ
Osseus, LLC
Orthopedic · 139d
Cleared Mar 11, 2003
CCD CAMERA, MODEL PKP-06000-000
K024085 · IZJ
Perkins Electronics Co.
Radiology · 90d
Cleared Mar 11, 2003
REPROCESSED COMPRESSION SLEEVES
K024087 · JOW
Alliance Medical Corp.
Cardiovascular · 90d
Cleared Mar 11, 2003
VACUFLASH BIOPSY SYSTEM
K024089 · KNW
Bip USA, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 11, 2003
VICTOREEN THEBES II, MODEL 7020
K024284 · IYE
Syncor Radiation Management
Radiology · 78d
Cleared Mar 11, 2003
RAPID PROGRAMMAR
K030118 · GZB
Advanced Neuromodulation Systems
Neurology · 57d