BEUDAMED
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    ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Perfadex Plus

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·October 11, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 12, 2012

    POSTERIOR VICTRECTOMY PACK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQC·June 24, 2015