BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ANTI-SCI-70 ANTIBODY TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    Freedom Infinia™ Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code DXY·February 9, 2013

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 7, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 23, 2014

    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