BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    DIALBUMIN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Synapse 3D Blood Flow Analysis

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 4, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2014

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 7, 2012

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020