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

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    POST-AURICULAR HEARING AID MODEL ASP-103

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INTERA I/T

    FDA 510(k)
    FDA Class 2 ·Radiology

    STEREOS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 15, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 31, 2012

    SOFTCLIX® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 24, 2010

    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