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

Filters: Cleared only ×
176,076 results
73273–73296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2003
GEM, MODEL 004110
K030464 · BZG
Collins Medical, Inc.
Anesthesiology · 30d
Cleared Mar 14, 2003
GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET
K030467 · FPA
Iv Medical, Inc.
General Hospital · 30d
Cleared Mar 14, 2003
GDC STRETCH RESISTANT DETACHABLE COIL
K030475 · HCG
Boston Scientific, Target
Neurology · 29d
Cleared Mar 14, 2003
CPCA2000 COUNTERPULSATION SYSTEM
K030532 · DRN
Cpca2000, Inc.
Cardiovascular · 23d
Cleared Mar 14, 2003
MAS LIPID LEVEL 1 AND 2
K030679 · JJY
Medical Analysis Systems, Inc.
Chemistry · 10d
Cleared Mar 13, 2003
CANDELA GENTLE YAG LASER SYSTEM
K022923 · GEX
Candela Corp.
General & Plastic Surgery · 190d
Cleared Mar 13, 2003
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
K023105 · CIC
Elan Diagnostics
Chemistry · 176d
Cleared Mar 13, 2003
GYRUS PLASMA SKIN RESURFACING SYSTEM
K023111 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 175d
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