BEUDAMED
    580 results · 20ms · 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 ×

    Albomed GmbH

    Manufacturer
    🇩🇪 Germany·11 Basic UDI-DIs·11 Devices·HTCert (Health Technology Certification Ltd)

    VARELISA RECOMBI CTD SCREEN, MODEL 13096

    FDA 510(k)
    FDA Class 2 ·Immunology

    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 16, 2022

    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 17, 2021

    ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·June 16, 2021

    2385C04210501

    Certificate
    MDD Annex II (excluding section 4)·Albomed GmbH·HTCert (Health Technology Certification Ltd)·11 Basic UDI-DIs

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    RESORBABLE FILLING AND RECONSTRUCTION DEVICES

    Device
    EU MDD · Eu Md Class 3 ·Albomed GmbH·On the market·27 countries

    ARTICARES PTE LTD

    Importer
    🇩🇪 Germany·1 Manufacturer

    Mindfield Biosystems Ltd.

    Importer
    🇩🇪 Germany

    iTD GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer