BEUDAMED
    8 results · 16ms · Sources: EU EUDAMED, US FDA

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    QBC SYSTEM HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    KNEECPM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    THIOGEL MEDIUM TUBE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·October 14, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 14, 2012

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·June 16, 2014

    SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 9, 2018

    Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·September 3, 2008