BEUDAMED
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    LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MACHNET CAROTIDS COIL ARRAY ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Radiology

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    ALIGN TO URETHRAL SUPPORT SYSTEM - HOOK

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code OTN·March 20, 2013

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·February 15, 2011

    LUPINE DRILL GUIDE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·March 31, 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