245 results
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49ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMERICAN EDWARDS LABORATORIES FLEXISCOPE
FDA 510(k)
FDA Class 2
·Orthopedic
CARPENTER EDWARDS BIOPROSTHESIS #35
FDA Adverse Event
Death
·AMERICAN EDWARDS LABORATORIES·Product code DYE·October 22, 1992
EDWARDS SWAN GANZ
FDA Adverse Event
Injury
·BAXTER EDWARDS LABORATORIES·Product code DYG·November 20, 1997
SWAN-GANZ, 7.5 FR
FDA Adverse Event
AMERICAN EDWARDS LABORATORIES·Product code DYG·January 16, 1996
PERCUTANEOUS SHEATH INTRODUCER SET
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DQY·November 13, 2015
PERCUTANEOUS SHEATH INTRODUCER SET
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DQY·October 9, 2015
INFUSION CATHETER, 7F
FDA Adverse Event
Other
·EDWARDS LIFESCIENCES·Product code DQO·April 28, 2003
*
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYE·July 16, 2013
NI
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 22, 2023
SEE H10
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 19, 2017
CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 10, 2015
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 11, 2012
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 12, 2012
CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 2, 2012
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 20, 2009
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 31, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES LLC·Product code DYE·November 19, 2019
REPLACEMENT HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 12, 2009
FOGARTY ARTERIAL EMBOLECTOMY CATHETER
FDA Adverse Event
Other
·EDWARDS LIFESCIENCES·Product code DXE·July 17, 2008
CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 11, 2012