BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    OMNI PLANE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TruSystem

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761996069·Hospital Device

    TS 7500

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761974081·TruSystem 7500 Hybrid (FC)

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code DQX·December 3, 2025

    CARTO™ 3 EP Navigation System V9.0 with PIU Plus

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRAGER PEEP SYSTEM D

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·February 25, 2025

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 6, 2014

    UNIDENTIFIED HIP IMPLANT OR INSTRUMENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·December 3, 2012

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 18, 2015

    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 2, 2025

    COBAS 6000 C (501) MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 21, 2025