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

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    ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE

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

    PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME

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

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 31, 2013

    HYDRATOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·August 28, 2008

    MITEK VAPR VIEW FOOTSWITCH

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code GEI·June 27, 2011

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·December 23, 2016

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·March 23, 2017

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·October 24, 2016

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·February 20, 2019

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·October 29, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·August 3, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·September 7, 2016

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·April 30, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·April 14, 2017

    GALAFLEX

    FDA Adverse Event
    Injury ·TEPHA, INC·Product code OOD·February 28, 2020

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·June 14, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·April 20, 2017

    MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·December 13, 2018

    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