17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Adverse Event
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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