BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    Contour ProtégéAI

    FDA 510(k)
    FDA Class 2 ·Radiology

    SmartHDM-510 System

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

    ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 1, 2011

    *

    FDA Adverse Event
    Malfunction ·*·Product code CBK·August 19, 2008

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022