BEUDAMED
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    ABUSCREEN ONLINE OPIATES 300 / 2000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450577912·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511909·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511923·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511930·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134120·Trial, TLIF, 27L OB STR 7Deg, 12mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511916·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511947·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511886·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511893·

    PROCLUDE-SENSITIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    ANIMAS VIBE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·March 20, 2013

    HILL ROM

    FDA Adverse Event
    Injury ·HILL ROM·Product code FNL·March 7, 2011

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 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