BEUDAMED
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    Hemochron Signature Elite

    FDA 510(k)
    FDA Class 2 ·Hematology

    9.3MHZ PENCIL PROBE 10'

    FDA UDI
    PARKS MEDICAL ELECTRONICS, INC.·00816787021561·

    VASOSTAT HEMOSTASIS DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 22, 2011

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016