BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Assut Filbloc Permanent Sutures

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SHIMADZU COLLIMATOR R-300

    FDA 510(k)
    FDA Class 2 ·Radiology

    MISSION OLYMPUS AU ISE CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 18, 2019

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·June 14, 2013

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2015

    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