BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    WAKO AUTOKIT C3

    FDA 510(k)
    FDA Class 2 ·Immunology

    AUTOQUANT PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 2, 2013

    PROMUS ELEMENT ?

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 15, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 16, 2011

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024