BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    IL TEST CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYLK PERSONAL LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·February 9, 2013

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 4, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 23, 2014

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part

    FDA Enforcement
    Class I ·Terminated·Tenacore LLC·April 14, 2021