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

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    GCE704 Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023322·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...

    SYNOVO HIP COMPONENTS

    FDA UDI
    Synovo Production·00814193025999·HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28...

    NEEDLE 26X3/8 IB

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 23, 2019

    ADHESIVE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMS ELEVATE PC

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    WALLSTENT RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

    NEEDLE 26X3/8 IB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY·Product code FMI·July 10, 2019

    WALLSTENT ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 22, 2025

    WALLSTENT ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC.·Product code MND·October 9, 2014

    BENEVIEW / MPM MODULE

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code MHX·May 21, 2013

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 24, 2015

    WALLSTENT? RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 23, 2019

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020