17 results · 24ms · 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

CARDIOMEMS

FDA Adverse Event
Injury ·ABBOTT MEDICAL/ ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.·Product code MOM·October 21, 2025

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

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014

AUTOPULSE NIMH BATTERY

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 20, 2013

ACCESS® 2 IMMUNOASSAY ANALYZER

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

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

LUCAS(T) CPR CHEST COMPRESSION SYSTEM

FDA Adverse Event
Injury ·JOLIFE AB·Product code DRM·September 9, 2015

LUCAS® CPR CHEST COMPRESSION SYSTEM

FDA Adverse Event
Injury ·JOLIFE AB·Product code DRM·September 9, 2015

EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS

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