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

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    KC 1A COAGULATION ANALYZER/SET

    FDA 510(k)
    FDA Class 2 ·Hematology

    IONOBOND

    FDA 510(k)
    FDA Class 2 ·Dental

    MODEL 6984M LEAD EXTENDER KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 12, 2012

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·October 30, 2009

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

    FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·February 11, 2013

    E3 TORQUE CONTROL MOTOR

    FDA Adverse Event
    Malfunction ·DENTSPLY TULSA DENTAL SPECIALTIES·Product code EBW·February 5, 2014

    TENDRIL ST

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

    PrisMax System, Product Code 955724

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KDI·March 15, 2022

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

    PrisMax System, Product Code 955724

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·May 4, 2022

    PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

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

    PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

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