BEUDAMED
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    8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CapsoCam Plus (SV-3) Capsule Endoscopy System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OPTI-FIX

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDH·March 7, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014