BEUDAMED
    829 results · 37ms · Sources: EU EUDAMED, US FDA

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    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 12, 2007

    SUNQUEST LABORATORY SMART

    FDA Adverse Event
    Malfunction ·SUNQUEST INFORMATION SYSTEMS·Product code JQP·April 29, 2011

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

    FDA Enforcement
    Class III ·Terminated·Sunquest Information Systems, Inc.·August 22, 2012

    ENDOAVF ACCESS KIT

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS INC.·Product code OEX·June 23, 2021

    PRELUDE IDEAL HYDROPHILIC SHEATH

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code OEX·April 21, 2021

    N/A

    FDA Adverse Event
    Malfunction ·Product code OEX·February 22, 2012

    FEMORAL INTRODUCER SHEATH AND HEMOSTASIS

    FDA Adverse Event
    Death ·MORRIS INNOVATIVE, INC.·Product code OEX·October 12, 2010

    UNKNOWN TRANSRADIAL SHEATH

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code OEX·June 27, 2022

    MINI ACCESS KIT

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code OEX·September 16, 2025

    ENDOAVF ACCESS KIT

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS INC.·Product code OEX·August 31, 2021

    AGILIS INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OEX·June 5, 2008

    N/A

    FDA Adverse Event
    Malfunction ·Product code OEX·December 21, 2011

    CLASSIC SHEATH 6FCLS-1006

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code OEX·January 29, 2016

    MEDTRONIC

    FDA Adverse Event
    Injury ·UNKNOWN·Product code OEX·September 26, 2012

    FLEXOR CHECK FLO INTRODUCER

    FDA Adverse Event
    Injury ·COOK INCORPORATED·Product code OEX·September 17, 2012

    PRELUDE SHEATH INTRODUCER

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code OEX·May 12, 2026

    N/A

    FDA Adverse Event
    Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS·Product code OEX·February 22, 2012

    N/A

    FDA Adverse Event
    Malfunction ·Product code OEX·March 9, 2012

    ENDOAVF® ACCESS KIT

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS INC.·Product code OEX·February 15, 2022

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·April 28, 2011