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

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    D-SCOPE III

    FDA 510(k)
    FDA Class 1 ·Radiology

    UNIFAST CALCIUM TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FIBEROPTIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 19, 2014

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·October 25, 2010

    SOFTCLIX ® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·December 24, 2012

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026