BEUDAMED
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    HERITAGE 10

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BOWIE-DICK MINI PAK, MODEL BD 115

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·January 22, 2013

    PATROL PUMP

    FDA Adverse Event
    Death ·ABBOTT NUTRITION·Product code LZH·December 7, 2010

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 9, 2014

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021