BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    OPTIX H2 Patient Specific Instrument System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2024

    C21617 DE LIFE SYSTEMS $PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·November 7, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    CP82200 I MIRANDOLA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012

    CP85341 FR PARIS

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·August 15, 2013

    EMORY/CL/KNNSTN ATLANTA GA1

    FDA Adverse Event
    Other ·SORIN GROUP USA·Product code DWF·August 19, 2010

    DUKE UNIV DURHAM NC 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016

    COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code KFM·February 29, 2016

    REVOLUTION CENTRIFUGAL BLOOD PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·July 20, 2018

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·October 6, 2016

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code KFM·October 5, 2016

    PULLUP

    FDA Adverse Event
    Malfunction ·S.B.M. SAS·Product code MBI·April 12, 2023

    CT SCREW DOUBLE LEAD LOCK, Ø3.5MM X 26MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code KTW·March 3, 2025