BEUDAMED
    25 results · 24ms · Sources: EU EUDAMED, US FDA

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    SOMATOM Definition Edge

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVERDIXIE

    FDA UDI
    CAREMATE MEDICAL DEVICE CO., LTD·06971329980042·

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138128309·ELBOW IMMOB FOAM W/STAYS, SM/CHILD

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180523285·Shucker - 6mm

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619041960·Central Venous Catheter, Heparin Coated, 2 Lume...

    SPECTRANETICS LLD CS, MODEL 518-039

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHO-1(NOT FINALIZED)

    FDA 510(k)
    FDA Class 2 ·Dental

    CHLORAPREP ONE STEP

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·July 2, 2021

    INTELLAMAP ORION

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

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 3, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 27, 2014

    KINETIX PTCA GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·June 29, 2011

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020

    INTELLAMAP ORION?

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