BEUDAMED
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    C3 ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033446775·

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    FDA UDI
    FGX INTERNATIONAL INC.·00193033446782·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033446751·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033446737·

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    FDA UDI
    FGX INTERNATIONAL INC.·00193033446744·

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    FDA UDI
    FGX INTERNATIONAL INC.·00193033446768·

    UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 8, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 15, 2025

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·May 27, 2026

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·May 5, 2026

    SHUNT KIT, ULTRA SMALL, MEDIUM PRESSURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·March 1, 2013

    EYE SURGERY STRETHCER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 3, 2011

    PRECISE SDS SELF EXPANDING

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·August 15, 2014

    DERMATOME BLADES

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL, INC.·Product code GFD·October 9, 2023

    DERMATOME BLADES

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL, INC.·Product code GFD·October 9, 2023

    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