BEUDAMED
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    MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 60mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665033731·

    Stainless Steel

    FDA UDI
    INTEGRA LIFESCIENCES CORPORATION·10381780027751·Polyaxial Screw, 4.00mm x 60mm

    Logical C-Series

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215004989·

    Stainless Steel

    FDA UDI
    Seaspine Orthopedics Corporation·10889981022112·Polyaxial Screw, 4.00mm x 60mm

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981015558·Solid Polyaxial Screw, 4.00mm x 60mm

    Coral

    FDA UDI
    INTEGRA LIFESCIENCES CORPORATION·10381780011255·Polyaxial Screw 4.00mm x 60mm

    Coral

    FDA UDI
    INTEGRA LIFESCIENCES CORPORATION·10381780013471·Solid Polyaxial Screw, 4.00mm x 60mm

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981014971·Polyaxial Screw 4.00mm x 60mm

    E-CUBE 9

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971352·

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2013

    HERO GRAFT

    FDA Adverse Event
    Death ·HEMOSPHERE, INC.·Product code DSY·September 27, 2014

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

    Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 29, 2021

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·June 22, 2018

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·March 29, 2016

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·August 29, 2016