BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    C-DAK 4000 ARTIFICIAL KIDNEY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EPTONE BACK-UP BROTH, VACUTAINER

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 30, 2014

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 10, 2012

    ACCU-CHEK INFORM METER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 25, 2007

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024