BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    TMINI Miniature Robotic System

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO: ZILVER 635 BILIARY STENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IntellaMap Orion High Resolution Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

    GUIDEWIRE 1.1MM X 15?

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code FZX·November 11, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 12, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 25, 2011

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD.·Product code FGE·April 11, 2011

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 5, 2012

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

    ZILVER 635 SELF EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 13, 2014

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 30, 2014

    ZILVER 635 BILIARY SELF EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 13, 2012

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 2, 2014

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·July 16, 2014

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD.·Product code FGE·April 14, 2011

    INTELLAMAP ORION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024