43 results · 24ms · Sources: EU EUDAMED, 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