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

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    FIX-C 3D Ti ACIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHLORAPREP ONE STEP HI-LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KXF·December 2, 2020

    Tactoset

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIB Stent Placement Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 11, 2014

    COLLEAGUE

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

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