BEUDAMED
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    ETV, ELECTRONIC VISION AID

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·January 20, 2016

    0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·January 20, 2016

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code GCJ·March 9, 2026

    Oral Electronic Vision Aid

    FDA classification
    FDA Class 2 ·Oral Electronic Vision Aid

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·October 14, 2014

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·July 29, 2014

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·July 29, 2014

    CRYSTALENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·December 21, 2010

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·May 8, 2015

    Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 4, 2007

    Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 4, 2007

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·March 23, 2020

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·March 23, 2020

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 28, 2021

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·April 25, 2015

    AKREOS MICROINCISION IOL

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·July 7, 2017

    Aid, Vision, Electronic, Battery-Powered

    FDA classification
    FDA Class 1 ·Aid, Vision, Electronic, Battery-Powered

    Aid, Vision, Electronic, Ac-Powered

    FDA classification
    FDA Class 1 ·Aid, Vision, Electronic, Ac-Powered

    SURPASS STENT DELIVERY SYSTEM 4MMX30MM

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR CORK·Product code OUT·June 20, 2019