BEUDAMED
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    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·June 20, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 14, 2021

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 13, 2017

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·February 5, 2018

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Enforcement
    Class II ·Terminated·LivaNova USA·May 30, 2018

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 7, 2014

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Recall
    Terminated ·LivaNova USA·Product code DWC·April 20, 2018

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 6, 2017

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 23, 2017

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 3, 2017

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 16, 2018

    Mucicarmine

    FDA classification
    FDA Class 1 ·Mucicarmine

    IDENT H.C. S.R.L.

    Manufacturer
    🇮🇹 Italy

    HMC PREMEDICAL S.P.A.

    Manufacturer
    🇮🇹 Italy

    Steripharm Ltd Fzc

    Manufacturer
    🇦🇪 United Arab Emirates

    Medicina Limited

    Manufacturer
    1 Importer

    Vasmed Technologies Ltd Fzc

    Manufacturer
    🇦🇪 United Arab Emirates

    Tokai Optical MEA (FZC)

    Manufacturer
    🇦🇪 United Arab Emirates

    HDC S.R.L.

    FDA registration
    HDC S.R.L.·3 products·🇮🇹 Italy

    HMC Premedical S.p.A.

    FDA registration
    HMC Premedical S.p.A.·3 products·🇮🇹 Italy