BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    EMG MODEL SUA01 SUCTION UNIT

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

    AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER

    FDA 510(k)
    FDA Class 2 ·Neurology

    METAVISION CLINICAL INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 4, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE MED SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·February 15, 2011

    INSIGNIA ULTRA

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. 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