BEUDAMED
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    PACIFIC HEMOSTASIS REFERENCE EMULSION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481967·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481950·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481981·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481998·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033482254·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481943·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033482001·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481974·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033482261·

    COLLES C SERIES FRAME STERILE PACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERSYST REVEAL

    FDA 510(k)
    FDA Class 2 ·Neurology

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 20, 2013

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    FDA Adverse Event
    Injury ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·March 8, 2011

    INSYNC II MARQUIS

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code NIK·March 10, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014