43 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FARADRIVE Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Albumin BCG2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 9, 2012
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 2, 2014
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DYG·February 26, 2026
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 21, 2013
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 12, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 13, 2025
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 9, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 16, 2016
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·November 12, 2008
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 2, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 21, 2013
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·November 26, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 20, 2025