11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486004699·MCK INLAY TRIAL (SIZE 4 X 8.5mm)
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486004682·MCK INLAY TRIAL (SIZE 4 X 7.5mm)
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486004675·MCK INLAY TRIAL (SIZE 4 X 6.5mm)
MEDISIZE GOLD HEATER AND BOOSTER
FDA 510(k)
FDA Class 2
·Anesthesiology
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
FDA 510(k)
FDA Class 2
·Radiology
MONTERIS MEDICAL NEUROBLATE SYSTEM
FDA Adverse Event
Malfunction
·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 14, 2013
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·July 21, 2011
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·September 16, 2008
GOLDTRACE FETAL SPIRAL ELECTRODE
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code HGP·December 11, 2017