BEUDAMED
    16 results · 18ms · Sources: EU EUDAMED, US FDA

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    NIO-P

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NIO+ Adult

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NIO-I

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.

    FDA Enforcement
    Class II ·Terminated·Waismed Ltd·September 7, 2016

    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    aiOS

    Device
    EU MDR · Eu Md Class 1 ·Aidoc Medical Ltd.·On the market·12 countries

    Alpha Bio Tec Ltd.

    Manufacturer
    🇮🇱 Israel·1 Importer

    Theranica Bio-Electronics Ltd

    Manufacturer
    🇮🇱 Israel·1 Basic UDI-DI·1 Device·3 Importers

    Bio-Technology General (Israel) Ltd.

    Manufacturer
    🇮🇱 Israel·3 Importers

    ALPHA-BIO TEC

    FDA registration
    ALPHA-BIO TEC·1 product·🇮🇱 Israel

    THERANICA BIO-ELECTRONICS LTD.

    FDA registration
    THERANICA BIO-ELECTRONICS LTD.·1 product·🇮🇱 Israel

    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.

    FDA registration
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.·2 products·🇮🇱 Israel

    Nerivio

    Device
    EU MDR · Eu Md Class 2a ·Theranica Bio-Electronics Ltd·On the market·3 countries

    aiOS

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Aidoc Medical Ltd.·1 device

    Nerivio

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Theranica Bio-Electronics Ltd·1 device