BEUDAMED
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    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

    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012

    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    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

    Toshiba Ultimax DREX-ULT80 X-ray generator

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·March 22, 2017

    Toshiba Kalare DREX-KL80 X-ray generator

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·March 22, 2017

    5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

    6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012