19 results · 42ms · Sources: EU EUDAMED, US FDA

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P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 23, 2024

P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2025

RESOLUTE ONYX RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·January 31, 2019

RESOLUTE INTEGRITY RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·April 9, 2019

MICRA

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code PNJ·December 30, 2019

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 1, 2026

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 15, 2026

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·March 27, 2025

UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code OMI·July 5, 2011

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 30, 2013

PALACOS R+G BONE CEMENT

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code LOD·August 29, 2008

TISSUE HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 11, 2020

SEE. H10.

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·December 1, 2020

REPLACEMENT HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 13, 2020

REPLACEMENT HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·May 29, 2019

SEE H11

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·February 27, 2025

EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 27, 2024

RESOLUTE ONYX RX

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·July 1, 2021

MICRA

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code PNJ·December 27, 2019