BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    FLUOROMATIC ANALYZER AND AUTOSAMPLER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MT II SYSTEM - SERUM ALBUMIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·May 5, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 15, 2012

    CUSTOM ANGIOGRAPHIC KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·August 6, 2010

    4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·December 2, 2022

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025