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    INSIGHT MEDICAL SYSTEMS, INC

    FDA registration
    INSIGHT MEDICAL SYSTEMS, INC·3 products·🇺🇸 United States

    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.

    FDA Enforcement
    Class II ·Terminated·Insight Instruments, Inc.·May 22, 2013

    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.

    FDA Recall
    Terminated ·Insight Instruments, Inc.·Product code HMX·March 15, 2013

    DA VINCI SP

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·July 7, 2022

    O-ARM O2 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OWB·November 28, 2017

    FUSION¿ ENT NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 1, 2019

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·January 14, 2022

    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013