BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    HDL EZ-TZ3 CHOLESTEROL REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MYLABSSOGNO

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMBI SELF PROPELLED SHOWER COMMODE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·November 20, 2012

    ARIS TRANS-OBTURATOR

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FTL·August 21, 2013

    ZIMMER TRABECULAR METAL HUMERAL STEM

    FDA Adverse Event
    Malfunction ·ZIMMER INC.·Product code HSD·September 17, 2010

    Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017