BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    RnD TE and RnD SE

    FDA 510(k)
    FDA Class 2 ·Dental

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304456167·

    DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ORTHOSORB RESORBABLE PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSS AVL POLY TIB BUSHING SET

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·December 19, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·June 16, 2011

    VIVA QUAD XT

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014

    BD¿ NEXIVA SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019

    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