BEUDAMED
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    Filters Country: Germany ×

    B. & W. bioCARE GmbH

    Manufacturer
    🇩🇪 Germany

    SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE¿ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

    FDA Enforcement
    Class II ·Ongoing·Pajunk GmbH·November 6, 2019

    QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NDI Europe GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    NDD Medizintechnik GmbH

    Importer
    🇩🇪 Germany

    NDD Medizintechnik GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    Novanta Europe GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    B. & W. bioCARE GmbH

    Importer
    🇩🇪 Germany

    NDI Europe GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer·17 Devices

    Johner Medical GmbH

    Authorized representative
    🇩🇪 Germany·12 Manufacturers·119 Devices

    NDS Surgical Imaging LLC - Zweigniederlassung Deutschland

    Authorized representative
    🇩🇪 Germany

    B. & W. bioCARE GmbH

    System producer
    🇩🇪 Germany

    eResearchTechnology GmbH

    Importer
    🇩🇪 Germany·2 Manufacturers

    MEyeTech GmbH

    Importer
    🇩🇪 Germany·8 Manufacturers

    medac GmbH

    Importer
    🇩🇪 Germany·7 Manufacturers

    blnk GmbH

    Importer
    🇩🇪 Germany·14 Manufacturers

    Medical Technology Promedt Consulting GmbH

    Authorized representative
    🇩🇪 Germany·194 Manufacturers·10009 Devices