44 results · 38ms · Sources: EU EUDAMED, US FDA

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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