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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026

ST. JOSEPH HSP BALTIMORE MD1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

ONYX AVM

FDA Adverse Event
Injury ·COVIDIEN·Product code MFE·July 10, 2015

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

VASOVIEW HEMOPRO EVH SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·February 1, 2011

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

SMART, PERFUSION PACKS, CONNECTORS, TUBING

FDA Adverse Event
Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023

CSC14 CARDIOLOGIA HEAT EXCHANGER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTR·March 10, 2016

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTR·November 20, 2015

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010