BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    SMEARCLEAR

    FDA 510(k)
    FDA Unclassified ·Unknown

    LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BIOTECH B990K VIVI WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LEAD LOCKING DEVICE

    FDA Adverse Event
    Death ·SPECTRANETICS CORPORATION·Product code MFA·October 27, 2012

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·March 27, 2013

    CORE INTRA-ORAL BLADE

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND, LTD.·Product code GFA·February 24, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE SJ·Product code JPA·March 27, 2008

    OT INDUO METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 30, 2011

    OT INDUO METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 10, 2011

    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

    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018