BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    EXEL COMFORTPOINT INSULIN PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ITI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LINOX SD 65/16

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·March 26, 2013

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FFL·March 17, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 19, 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