270 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Adverse Event
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GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code PRL·January 4, 2021
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
PROLIEVE THERMODILITATION KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·May 11, 2016
ESHEATH INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 13, 2018
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·September 10, 2021
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·August 3, 2018
UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 3, 2025
EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2018
EDWARDS TRANSFEMORAL INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 18, 2020
EDWARDS TRANSCATHETER INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 12, 2020
EDWARDS TRANSCATHETER INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 13, 2020
SAPIEN VALVE UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 13, 2020
SAPIEN VALVE UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 13, 2020
EDWARDS THV VALVE UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·November 7, 2021
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 17, 2021
EDWARDS TF SHEATH UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021
UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 11, 2024