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

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    mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694022835·FPS 2.7mm 2.0mm Wedge Plate

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077248·FPS 2.7 2mm Wedge Plate Sterile Qty 2

    FEMORAL HOOK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOGIQ S7 EXPERT, LOGIQ S7 PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    SILVERHAWK LX-M PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·FOX HOLLOW TECHNOLOGIES·Product code MCW·November 18, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    ITREL II

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014