BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    NARROW NECK TEMPORARY COPING

    FDA 510(k)
    FDA Class 2 ·Dental

    FLOWTRON UNIVERSAL, MODEL AC600

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDTRONIC AVE BRIDGE X3 STENT

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

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·October 30, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 14, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 22, 2013

    SUPER TURBOVAC WITH INTEGRATED CABLE

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code GEI·July 2, 2008

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code DHA·April 27, 2011

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 27, 2020

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022