BEUDAMED
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    OQY INTRAUTERINE BALLOON

    FDA Adverse Event
    Injury ·COOK INC·Product code OQY·August 16, 2021

    SURGPN,270X5,PBI,-,OQI,5

    FDA Adverse Event
    Injury ·HALYARD - IRVINE·Product code MEB·June 14, 2016

    SURGPN,270X5,PBI-AM,-,OQI,5

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code MEB·September 14, 2015

    HYHSURGPN,400X2D,PBI-AM,-,OQI,5

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code MEB·May 11, 2017

    HYHSURGPN,400X2D,PBI-AM,-,OQI,5

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code MEB·May 11, 2017

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code OQY·November 14, 2023

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·May 7, 2018

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    FDA Enforcement
    Class II ·Terminated·Clinical Innovations, LLC·October 21, 2015

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    FDA Recall
    Terminated ·Clinical Innovations, LLC·Product code OQY·January 5, 2015

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·December 1, 2016

    EBB COMPLETE TAMPONADE SYSTEM

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code OQY·August 4, 2015

    EXP ACETABULAR SHELL AND LINER

    FDA Adverse Event
    STELKAST, INC.·Product code OQI·July 30, 2015

    EBB COMPLETE TAMPONADE SYSTEM

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code OQY·July 1, 2015

    EBB COMPLETE TAMPONADE SYSTEM

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code OQY·July 27, 2015

    EBB COMPLETE TAMPONADE SYSTEM

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code OQY·December 23, 2014

    EBB COMPLETE TAMPONADE SYSTEM

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code OQY·December 29, 2014

    JADA SYSTEM

    FDA Adverse Event
    Malfunction ·ALYDIA HEALTH·Product code OQY·May 23, 2021

    JADA SYSTEM

    FDA Adverse Event
    Malfunction ·ALYDIA HEALTH·Product code OQY·May 23, 2021

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·June 10, 2021

    G7 FINNED 4 HOLE SHELL 54F

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code OQI·April 19, 2021