BEUDAMED
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    Locking Screw Ø5 x 120mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Locking Screw Ø5 x 120mm

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·1 device

    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

    FDA Enforcement
    Class II ·Terminated·Aerogen Ltd.·October 29, 2014

    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

    FDA Enforcement
    Class II ·Terminated·Aerogen Ltd.·October 29, 2014

    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

    FDA Enforcement
    Class II ·Terminated·Aerogen Ltd.·October 29, 2014

    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

    FDA Enforcement
    Class II ·Terminated·Aerogen Ltd.·October 29, 2014

    Brandshapers Ltd

    Importer
    🇮🇪 Ireland·1 Manufacturer

    Medivent Ltd

    Importer
    🇮🇪 Ireland

    Caragen Ltd

    Importer
    🇮🇪 Ireland·2 Manufacturers

    BoMo Ltd

    Importer
    🇮🇪 Ireland

    Aerogen Ltd

    Importer
    🇮🇪 Ireland

    Camida Ltd

    Importer
    🇮🇪 Ireland

    MyBio Ltd

    Importer
    🇮🇪 Ireland

    NatExport Ltd

    Importer
    🇮🇪 Ireland

    Ottobock Ltd

    Importer
    🇮🇪 Ireland

    Incereb Ltd

    Importer
    🇮🇪 Ireland·1 Manufacturer

    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·July 31, 2024

    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.

    FDA Enforcement
    Class II ·Terminated·Cook Ireland Ltd.·September 12, 2012