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    MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011935·Zirlux 16+ D4 95X16

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326510·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326459·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326497·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326442·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326473·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326480·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326527·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326466·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326435·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326503·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033326534·

    STATLYTE NA/K/CL/LI ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPL-50 SPIROLYSER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·March 23, 2018

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·March 7, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 15, 2014

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 11, 2008