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

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    ACR 2500 CARDIOTOMY RESERVOIR FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KOLIBRI IMAGE GUIDED SURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 1, 2014

    SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRO

    FDA Adverse Event
    Death ·ONSET MEDICAL CORPORATION·Product code DYB·November 14, 2012

    DIDECO ELECTA

    FDA Adverse Event
    Other ·Product code CAC·September 16, 2010

    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