BEUDAMED
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    TRANS1 AXIALIF 2-LEVEL OR II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUSAM TOTAL ALBUMIN ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NUMED Z-MED PTV CATHERERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC MINIMED·Product code OYC·April 23, 2013

    EON MINI IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 13, 2011

    2.3 TURBO ELITE

    FDA Adverse Event
    Injury ·SPECTRANETICS CORP.·Product code GEX·July 11, 2008

    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