BEUDAMED
    9 results · 16ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Germany ×

    Jappo Siegfried Wölfle, e. Kfm.

    Manufacturer
    🇩🇪 Germany

    STERILIZATION TRAY ACCESSORIES ENT/CMF

    Device
    EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

    Universal CMF System

    FDA 510(k)
    FDA Class 2 ·Dental

    Stryker CMF MEDPOR Priority Customized Implant Kit

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

    IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    KM-Enke GmbH

    Importer
    🇩🇪 Germany

    LOGON OMF Bioactive Systems GmbH

    System producer
    🇩🇪 Germany

    Llins Service & Consulting GmbH

    Authorized representative
    🇩🇪 Germany·39 Manufacturers·556 Devices