BEUDAMED
    12 results · 31ms · Sources: EU EUDAMED, US FDA

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    Exam Vue PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    LANDANGER

    FDA UDI
    LANDANGER·03661219432531·

    THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX

    FDA 510(k)
    FDA Unclassified ·Unknown

    THERA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DXY·October 10, 2014

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

    DEKA MOTUS AX

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 25, 2018

    DEKA MOTUS AX

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 9, 2023

    SKINTACT

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·January 25, 2022

    DEKA MOTUS AX

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 6, 2024

    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