BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122

    FDA 510(k)
    FDA Class 1 ·Hematology

    CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING

    FDA 510(k)
    FDA Class 2 ·Radiology

    BioPlex 2200 Lyme Total

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 19, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·October 21, 2010

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MED CORP·Product code MKJ·November 13, 2012

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015