44 results
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38ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Adverse Event
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ALINITY I TOTAL PSA REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·November 17, 2025
DEPUY ASR FEM IMPLANT SZ 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 20, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 25, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 31, 2014
ARCHITECT TOTAL PSA
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·February 25, 2026
ALINITY I TOTAL PSA REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·May 20, 2025
ALINITY I TOTAL PSA REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·April 21, 2025
HANCOCK
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·January 5, 2021
MEDTRONIC SURGICAL TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 11, 2020
MELODY TRANSCATHETER PULMONARY VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·December 11, 2020
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 9, 2021
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 9, 2021
MEDTRONIC SURGICAL CONDUIT
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 22, 2024
ALINITY I TOTAL PSA REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·December 16, 2025
CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code MWH·November 19, 2020
MEDTRONIC SURGICAL CONDUIT
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 23, 2021
HANCOCK
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 9, 2022
MELODY TRANSCATHETER PULMONARY VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·January 4, 2021
MEDTRONIC SURGICAL TISSUE VALVE
FDA Adverse Event
Injury
·HEART VALVES SANTA ANA·Product code LWR·January 13, 2021
MEDTRONIC SURGICAL CONDUIT
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·January 29, 2021