BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    Azurion R2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741818300·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674181830060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1818300·18mm H x 18mm W x 30mm L x 0 degrees XLIF

    FX V 135 stem

    FDA UDI
    FX SOLUTIONS·03701037318461·FX V135 LONG STEM TA6V CEMENTLESS Ø40/14 LG180m...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L181830120·18mm H x 18mm W x 30mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X181830120·18mm H x 18mm W x 30mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X18183080·18mm H x 18mm W x 30mm L x 8 degrees XLIF

    IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZMACHINE, MODEL DT-100

    FDA 510(k)
    FDA Class 2 ·Neurology

    ITREL 3

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 21, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 28, 2011

    ENDO CATCH II

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·October 13, 2014

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026