BEUDAMED
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    SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867050730·LO-PRO SCRW,TI,3.5MMX 48MM

    AVIE A1C TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 25, 2014

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code JDI·January 2, 2013

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 8, 2010

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012