BEUDAMED
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    MODIFICATION TO PLEXOLONG SETS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II

    FDA 510(k)
    FDA Class 2 ·Radiology

    SNAP EEG MONITOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·March 19, 2020

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 21, 2014

    ZIMMER NATURAL NAIL THREADED PIN

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·February 27, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·March 13, 2014

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Injury ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·March 15, 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