9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Adverse Event
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PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
SIGMA SPECTRUM INFUSION PUMP
FDA Adverse Event
Injury
·SIGMA LLC·Product code FRN·August 10, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
HIGH FLOW INSUFFLATION UNIT
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code HIF·May 11, 2022
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·September 24, 2024
RIPTIDE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 9, 2024
REACT CATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·April 9, 2024
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 9, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·September 24, 2024