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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
36913–36936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2014
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
K133441 · MKJ
Bio-Detek, Inc.
Cardiovascular · 332d
Cleared Oct 10, 2014
EPIC 10
K140120 · GEX
Biolase, Inc.
General & Plastic Surgery · 267d
Cleared Oct 10, 2014
INTEGRA EXTERNAL FIXATION SYSTEM
K140463 · KTT
Ascension Orthopedic
Orthopedic · 228d
Cleared Oct 10, 2014
MECA XPRESSFISH
K140619 · MYI
Advandx, Inc.
Microbiology · 213d
Cleared Oct 10, 2014
OSTOM-I ALERT
K140938 · EXB
11 Health and Technologies, LLC
Gastroenterology & Urology · 182d
Cleared Oct 10, 2014
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
K141106 · OUR
Folsom Metal Products, Inc. Dba...
Orthopedic · 164d
Cleared Oct 10, 2014
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K141399 · GZB
Stimwave Technologies Incorporated
Neurology · 135d
Cleared Oct 10, 2014
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
K141869 · GWM
Hemedex Incorporated
Neurology · 91d
Cleared Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
K142014 · DQY
MicroVention, Inc.
Cardiovascular · 78d
Cleared Oct 10, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
K142033 · PCH
Nanospere,Inc.
Microbiology · 77d
Cleared Oct 10, 2014
QUANTRA
K142037 · LLZ
Hologic, Inc.
Radiology · 74d
Cleared Oct 10, 2014
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K142160 · IYN
Ge Healthcare
Radiology · 65d
Cleared Oct 10, 2014
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
K142323 · IYN
Ge Medical Systems Israel , Ltd.
Radiology · 51d
Cleared Oct 10, 2014
AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch...
K142614 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 24d
Cleared Oct 10, 2014
Acuson SC2000 Diagnostic Ultrasound System
K142628 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 24d
Cleared Oct 09, 2014
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K132592 · DYB
Cook, Inc.
Cardiovascular · 416d
Cleared Oct 09, 2014
IEVA REHABILITATIVE POSITIONAL DEVICE
K133990 · HIR
Remendium Labs, LLC
Gastroenterology & Urology · 286d
Cleared Oct 09, 2014
COROENT TI-C SYSTEM
K140319 · MAX
Nuvasive, Inc.
Orthopedic · 241d
Cleared Oct 09, 2014
ITCLAMP 50
K140805 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 191d
Cleared Oct 09, 2014
BLOOD PRESSURE MONITOR
K141416 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 133d
Cleared Oct 09, 2014
PRISM ZIRCONIA, ST-98
K141659 · EIH
A & D Dental Innovations
Dental · 111d
Cleared Oct 09, 2014
BIOMET FUSION SYSTEM
K141791 · OVD
Biomet Spine
Orthopedic · 99d
Cleared Oct 09, 2014
LYRA PARAINFLUENZA VIRUS ASSAY
K141927 · OOU
Quidel Corporation
Microbiology · 85d
Cleared Oct 09, 2014
LYRA ADENOVIRUS ASSAY
K141931 · OCC
Quidel Corporation
Microbiology · 85d