BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    TAPE, VASCULAR, 1/4 DACRON

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·April 18, 2014

    M2A-MAGNUM TAPER ADAPTER 42-50MM STANDARD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 26, 2012

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code INK·July 9, 2010

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage 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

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017