BEUDAMED
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    CAPTURE-R READY INDICATOR RED CELLS

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·February 19, 2014

    IMPLANT GUIDANCE SYSTEM APPLICATOR SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·April 6, 2016