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

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    LIGHT WEIGHT ALUMINUM WALKER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Couture Essence

    FDA UDI
    Carolon Company·00078301881444·

    Couture Essence

    FDA UDI
    Carolon Company·00078301821440·

    SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·April 25, 2014

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·October 23, 2012

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 25, 2010

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 9, 2015