BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    OsteoCool V-3 RF Ablation System

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

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    BioCare Safety Needles

    FDA UDI
    BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036077969·

    BD INSYTE AUTOG BC PNK 20GA X 1.16IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 30, 2024

    BD INSYTE AUTOG BC PNK 20GA X 1.16IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 30, 2024

    TARGON FN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 19, 2022

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 23, 2024

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 13, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 7, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·July 7, 2011

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 15, 2023

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·June 28, 2023

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2021

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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