BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    myplant two Implant

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Hager & Meisinger GmbH·15 devices

    i3 TWO direct

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·i3 Membrane GmbH·1 device

    i3 TWO connect

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·i3 Membrane GmbH·1 device

    NVT GmbH

    Authorized representative
    🇩🇪 Germany·3 Manufacturers·185 Devices

    MedNet EC-REP IIb GmbH

    Authorized representative
    🇩🇪 Germany·32 Manufacturers·165 Devices

    DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·April 28, 2021

    Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·October 30, 2019

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices