BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    RNA MEDICAL HEMAT CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BASE

    FDA UDI
    Nuvasive, Inc.·00887517702005·BASE HL Trial, 6x38x28mm 30°

    therMaxTherMax Blood Warmer

    FDA UDI
    BAXTER HEALTHCARE CORPORATION·00085412639505·The TherMax blood warmer is an accessory device...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704287097·

    OPHTIMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INFANT REFLUX SLING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 13, 2014

    WALLFLEX¿ BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·February 11, 2013

    ISOFLEX LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

    FDA Recall
    Open, Classified ·VANTIVE US HEALTHCARE LLC·Product code KDI·July 28, 2025

    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

    FDA Enforcement
    Class II ·Ongoing·VANTIVE US HEALTHCARE LLC·September 3, 2025

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019