BEUDAMED
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    ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KGC·August 10, 2020

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    MIC-KEY* G-14 INTRODUCER KIT

    FDA Adverse Event
    Injury ·HALYARD HEALTH·Product code KGC·October 20, 2016

    MIC* G-14 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·December 8, 2016

    MIC-KEY* G-14 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·October 24, 2016

    MIC-KEY* G-18 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·November 15, 2016

    ENDOVIVE¿ ONE STEP BUTTON¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KGC·December 1, 2016

    HALYARD

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH, INC.·Product code KGC·October 25, 2016

    MIC-KEY* G-20 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·November 23, 2016

    MIC-KEY* G-16 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·November 17, 2016

    MIC-KEY* G-20 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·November 11, 2016

    MIC-KEY* G-20 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·November 21, 2016

    ENDOVIVE¿ ONE STEP BUTTON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KGC·August 19, 2015

    MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL)

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·August 5, 2015

    24 FR SERIAL DILATOR

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·August 20, 2015

    MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL)

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·July 22, 2015

    MIC* TJ FEEDING TUBE KIT 18 FR, 22CM (ENDO/RADIOL)

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code KGC·July 22, 2015

    ONE STEP BUTTON¿

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code KGC·February 27, 2012

    ENDOVIVE¿ ONE STEP BUTTON¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KGC·March 2, 2012