BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Wingman 18 Crossing Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BOD POD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHANGHAI PHOENIX MECHANICAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    LAMITRODE 88 60-CM LENGTH PADDLE LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 7, 2011

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 18, 2019

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 2, 2020

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 18, 2021

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·August 27, 2020

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 21, 2021

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·June 21, 2019

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·January 25, 2024

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·January 29, 2019

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 12, 2020

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·March 12, 2020

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·December 8, 2022

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 31, 2022

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·October 10, 2019

    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