BEUDAMED
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    FORCE EVALUATION AND TESTING SYSTEM (FETS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HD AUTOCLAVABLE CAMERA HEAD

    FDA Adverse Event
    Malfunction ·FET·Product code FET·April 9, 2025

    SEDECAL

    FDA UDI
    SEDECAL·08436046003033·The Proteus XR/f ET Radiographic Systems with (...

    SEDECAL

    FDA UDI
    SEDECAL·08436046002302·The Proteus XR/f ET Radiographic Systems with (...

    CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 26, 2017

    CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·October 27, 2017

    SONOSURG-G2

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·November 19, 2013

    SONOSURG-G2

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·November 5, 2014

    SONOSURG-G2

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·November 27, 2013

    SONOSURG - G2

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP·Product code LFL·November 8, 2012

    SONOSURG-G2

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·December 18, 2012

    QUANTUM ROLLER PUMP - 6"

    FDA Adverse Event
    Malfunction ·SPECTRUM MEDICAL LTD·Product code DTQ·April 22, 2026

    SONOSURG-G2 SET

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code LFL·December 24, 2014

    ULTRASONIC SURGICAL SYSTEM SONOSURG

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code LFL·October 28, 2015

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·July 29, 2025

    ULTRASONIC SURGICAL SYSTEM SONOSURG

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code LFL·February 29, 2016

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·August 10, 2022

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·August 10, 2022

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·June 9, 2021

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·April 22, 2021