BEUDAMED
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    NEUROSURGERY INSTRUMENTS, REUSABLE- OTHER

    Device
    EU MDR · Eu Md Class 1 ·MagForce NT GmbH·On the market

    DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER

    Device
    EU MDR · Eu Md Class 1 ·Luxamed GmbH & Co. KG·On the market·32 countries

    DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER

    Device
    EU MDR · Eu Md Class 1 ·Luxamed GmbH & Co. KG·On the market·32 countries

    W-Core Reusable Biopsy Instrument

    Device
    EU MDR · Eu Md Class 2a ·Wellgo Medical Products GmbH·On the market·1 country

    GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Medical Consult Implants GmbH·On the market·5 countries

    W-Core II Reusable Biopsy Instrument

    Device
    EU MDR · Eu Md Class 2a ·Wellgo Medical Products GmbH·On the market·1 country

    Reusable Biopsy Instrument

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Wellgo Medical Products GmbH·2 devices

    Reusable unsterile Instruments

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·PFM medical Titanium GmbH·3 devices

    Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·February 13, 2019