7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KNEE PROTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150768·K-WIRE - SINGLE TROCAR 1.6mm DIA x 230mm
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Response Ortho Metaphyseal Hinge Fixator System
FDA 510(k)
FDA Class 2
·Orthopedic
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·December 20, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 21, 2012