BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    WAGNER STERISET STERILIZATION CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ABBOTT ACCLAIM ENCORE, MODEL 12237

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BURR HOLE COVER, MODEL XX

    FDA 510(k)
    FDA Class 2 ·Neurology

    ITREL 3

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 29, 2015

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·March 29, 2011

    SELUTE PICOTIP LEAD

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 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

    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