BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ecoFIX®

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SMITH & NEPHEW IUR MORCELLATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CONTOUR® PLUS BLUE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2013

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

    CONTOUR® NEXT

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025

    CONTOUR® PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025

    Revogene, Catalog no. 610210. IVD test instrument

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