BEUDAMED
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    LP(A)-LATEX SEIKEN ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450472453·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481097·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481059·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481127·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481103·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481073·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481042·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481028·

    COLOSCREEN-ES

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUICK-CORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FCG·September 4, 2018

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973530·

    DRB1 SSP UNITRAY KIT WITH TAQ POLYMERASE

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORPORATION·Product code MZI·January 23, 2014

    MICRO DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·March 20, 2013

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·March 10, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·March 13, 2008

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    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