BEUDAMED
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    MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Isomedix Operations, Inc.

    FDA registration
    Isomedix Operations, Inc.·195 products·🇺🇸 United States

    BREAST BOLSTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702

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

    GORE EXCLUDER ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·March 25, 2013

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code HDD·March 22, 2011

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.,·Product code DSP·July 29, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 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