BEUDAMED
    15 results · 18ms · 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 ×

    Essenz HLM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Essenz HLM, Essenz ILBM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HLM TUBING SET WITH SOFTLINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HLM TUBING SET WITH BIOLINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.

    FDA Enforcement
    Class III ·Terminated·LivaNova Deutschland GmbH·March 23, 2022

    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

    FDA Enforcement
    Class II ·Ongoing·LivaNova Deutschland GmbH·December 4, 2024

    elm-plastic GmbH

    Manufacturer
    🇩🇪 Germany

    ELM-PLASTIC GMBH

    FDA registration
    ELM-PLASTIC GMBH·2 products·🇩🇪 Germany

    Salzkonzentrat 2LM-1000 l

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Biochem Bernburg GmbH·1 device

    HELM AG

    Importer
    🇩🇪 Germany·1 Manufacturer

    HELM Pharmaceuticals GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    LHM Medical Technology GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    HUM Gesellschaft für Homecare und Medizintechnik mbH

    System producer
    🇩🇪 Germany

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices