BEUDAMED
    40 results · 24ms · 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: Ireland ×

    DAU Secondary cut-off Multi-Drug Calibrator

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DAU Secondary cut-off Multi-Drug Calibrator

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

    Multichem P, Part Code 08P90-10

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    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

    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Aerogen Ltd

    Manufacturer
    🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)

    Medifill Ltd

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·National Standards Authority of Ireland (NSAI)

    Syncrophi Systems Ltd

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device·National Standards Authority of Ireland (NSAI)

    CutisSeal Topical B

    Device
    EU MDD · Eu Md Class 2a ·Medifill Ltd·On the market·1 country

    CutisSeal Topical H

    Device
    EU MDD · Eu Md Class 2a ·Medifill Ltd·On the market·1 country

    KEWS300

    Device
    EU MDD · Eu Md Class 2b ·Syncrophi Systems Ltd·On the market·1 country

    Aerogen USB Controller

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·7 countries

    Aerogen USB Controller

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·1 country

    Aerogen Ultra (10 Pack)

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·1 country

    Aerogen Solo Adult T-Piece 22mm

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·13 countries