BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    NOVA LITE(TM) DSDNA

    FDA 510(k)
    FDA Class 2 ·Immunology

    EnsoETM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERISUITE 1.6, VERISUITE-PARTICLE 1.6

    FDA 510(k)
    FDA Class 2 ·Radiology

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·TENEX HEALTH·Product code LFL·April 9, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 25, 2010

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025