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

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    ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SculpSure

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CENTRIFICHEM COMB. SERUM-BASED CALIB.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 10, 2014

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·October 13, 2010

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·December 20, 2012

    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