BEUDAMED
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    TITAN 11

    FDA 510(k)
    FDA Class 2 ·Radiology

    AF541

    FDA UDI
    Respironics, Inc.·00606959046467·AF541 Under the Nose Mask with Entrainment Elbo...

    IRRIGATION CHANNEL TUBING, MODEL 100135

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PREPEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MIS PRECISION NEURO, 2.5 MM

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·May 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 9, 2011

    GE OEC 7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

    N/A

    FDA Adverse Event
    Injury ·EL. EN. ELECTRONIC ENGINEERING SPA·Product code GEX·September 21, 2018

    DEKA SMARTXIDE2

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 22, 2021

    UNKNONW

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 9, 2018

    DEKA SMARTXIDE2

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 6, 2023

    UNKNOWN

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 7, 2022

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 4, 2019

    DEKA SMARTXIDE2

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 3, 2023

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023