BEUDAMED
    24 results · 19ms · Sources: EU EUDAMED, US FDA

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    X-CEN-TEK GmbH & Co.KG

    Manufacturer
    🇩🇪 Germany

    X-CEN-TEK GmbH & Co. KG

    FDA registration
    X-CEN-TEK GmbH & Co. KG·4 products·🇩🇪 Germany

    Trade Con GmbH

    Importer
    🇩🇪 Germany

    Albert Hohlkörper GmbH & Co. KG

    Importer
    🇩🇪 Germany·3 Manufacturers

    Centrifuge 5427R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·3 devices

    MiniSpin; MiniSpin Plus

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·2 devices

    Centrifuge 5920R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·6 devices

    Centrifuge 5910Ri

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·4 devices

    Centrifuge 5804; Centrifuge 5804R; Centrifuge 5810; Centrifuge 5810R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·16 devices

    Centrifuge 5702R; Centrifuge 5702RH; Centrifuge 5702

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·7 devices

    Centrifuge 5430; Centrifuge 5430R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·8 devices

    Centrifuge 5420

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·2 devices

    Centrifuge 5425R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·4 devices

    Centrifuge 5425; Centrifuge 5425R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·5 devices

    Centrifuge 5418R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·1 device

    TROGE Medical GmbH

    Importer
    🇩🇪 Germany·11 Manufacturers

    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·February 14, 2018

    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 6, 2014

    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

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 11, 2015