7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ES-100 ACCESSORIES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
FDA 510(k)
FDA Class 2
·Radiology
Trellis Reserve Infusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
TOTAL CARE BARIATRIC BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 4, 2014
PERIGEE SYSTEM WITH INTEPRO
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·January 25, 2013
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 17, 2010
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 2025