BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    GLUCOHEMOGLOBIN CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ECG Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EASYONE PRO RESPIRATORY ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 5, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025