BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    PEDIATRIC ARTERIAL BLOOD FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435064173·MCD Screw 4.0 x 12 mm M3 non lo...

    SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CINA-VCF

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 30, 2014

    FILTERWIRE EZ¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code NFA·November 20, 2012

    HARMONIC ACE 23CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 22, 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