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

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    OXYMIZER FLOW RESTRICTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MUELLER HINTON AGAR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 21, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 12, 2015

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·September 20, 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