35 results · 53ms · Sources: EU EUDAMED, US FDA

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AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·XLUMENA INC.·Product code PCU·November 12, 2014

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·XLUMENA INC.·Product code PCU·October 14, 2014

NAVIX ACCESS DEVICE

FDA Adverse Event
Injury ·XLUMENA, INC.·Product code GCJ·October 15, 2010

NAVIX ACCESS DEVICE

FDA Adverse Event
Injury ·XLUMENA INC.·Product code GCJ·August 22, 2011

NAVIX ACCESS DEVICE

FDA Adverse Event
Malfunction ·XLUMENA INC.·Product code GCJ·May 16, 2013

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Other ·XLUMENA, INC.·Product code PCU·July 29, 2014

NAVIX ACCESS DEVICE

FDA Adverse Event
Injury ·XLUMENA, INC.·Product code GCJ·April 4, 2011

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Injury ·XLUMENA INC.·Product code PCU·March 27, 2015

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Injury ·XLUMENA INC., A BOSTON SCIENTIFIC COMPANY·Product code PCU·June 16, 2015

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Injury ·XLUMENA INC., BOSTON SCIENTIFIC CO·Product code PCU·June 11, 2015

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·August 13, 2024

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·August 13, 2024

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Death ·XLUMENA INC., BOSTON SCIENTIFIC CO·Product code PCU·June 16, 2015

BIOGLUE- UNKNOWN CONFIGURATION

FDA Adverse Event
Injury ·ARTIVION, INC.·Product code MUQ·April 26, 2024

OCTARAY MAPPING CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·January 26, 2024

LASSOSTAR, 10P, DIA 15MM LOOP SIZE

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·May 16, 2023

IMPELLA

FDA Adverse Event
Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 30, 2026

OCTARAY MAPPING CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·November 4, 2025

IMPELLA

FDA Adverse Event
Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 14, 2026

IMPELLA

FDA Adverse Event
Injury ·ABIOMED, INC. - 1220648·Product code OZD·April 17, 2026