BEUDAMED
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    Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

    FDA 510(k)
    FDA Unclassified ·Unknown

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017965·K-Wire, Single Ended, Trocar Point, Diameter Si...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690110729·Patella Trial 29mm x 8mm

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690101932·All Poly 3 Peg Patella 29 mm x 8 mm

    ABI Instrument, Creo Electrosurgical System

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

    ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

    ISOFLEX OPTIM LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

    TAXUS? LIBERTÉ?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013