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

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    preCARDIA Occlusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TriVerse Tibial Offset Cutting Block

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215108687·

    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Multi-Link X2 ECG Cable and Leadwire System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 28, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE-SINGAPORE·Product code FRN·August 24, 2011

    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens

    FDA Enforcement
    Class II ·Ongoing·Diasorin Inc.·December 18, 2024