6 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ENOS Software Guided External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINITY OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
INSIGNIA ULTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·November 11, 2008
ACCU-CHEK SPIRIT ADAPTER
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·August 10, 2011
HYPERFORM
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code MJN·July 18, 2013