BEUDAMED
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    ENCORE SHOULDER REVISION GLENOID

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIDENT ACETABULAR SHELLS: PS-HA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    2520274-2013-02176

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·April 29, 2013

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 20, 2011

    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