BEUDAMED
    7 results · 55ms · Sources: EU EUDAMED, US FDA

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    STRETTA 8800 CATHETER AND ACCESSORIES KIT

    FDA Adverse Event
    Death ·MEDERI THERAPEUTICS / MEDERI RF LLC·Product code GEI·August 5, 2019

    SECCA

    FDA Adverse Event
    Injury ·MEDERI THERAPEUTICS INC.·Product code GEI·October 28, 2011

    SECCA

    FDA Adverse Event
    Injury ·MEDERI THERAPEUTICS INC.·Product code GEI·October 20, 2011

    MEDERI STRETTA CATHETER

    FDA Adverse Event
    Malfunction ·MEDERI THERAPEUTICS INC·Product code GEI·April 4, 2017

    Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580

    FDA Recall
    Terminated ·Mederi Therapeutics, Inc·Product code GEI·April 3, 2017

    Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580

    FDA Enforcement
    Class II ·Terminated·Mederi Therapeutics, Inc·May 17, 2017

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices