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

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    B-D ANGIOGRAPHIC CONTROL SYRINGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197485·AK3 PS-R Insert Trial Size 3, 18mm

    BIOTROL CALIBRANT LEVEL 3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIGITRON 3, LV ANALYSIS PROTCOL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 25, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·January 3, 2013

    ACTIVA RC

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·November 8, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020