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    Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems. It is used to intravenously facilitate the administration of contrast media and flushing solutions into the human vascular systems.

    FDA Enforcement
    Class II ·Terminated·Bracco Injeneering S.A.·December 26, 2018

    AxSOS 3Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AxSOS 3 Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AxSOS 3 Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EZplan

    Device
    EU MDD · Eu Md Class 1 ·SeedIMPULSE SA·On the market

    EZplan

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SeedIMPULSE SA·1 device

    399-00-00-DM

    Certificate
    MDD Annex II (excluding section 4)·SeedIMPULSE SA·ITALCERT SRL·1 Basic UDI-DI

    Biosensors Europe SA

    Manufacturer
    🇨🇭 Switzerland·185 Basic UDI-DIs·185 Devices·1 Importer·National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    Polichem SA, Lussemburgo, succursale di Mendrisio

    Manufacturer
    🇨🇭 Switzerland·53 Basic UDI-DIs·53 Devices·Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., Eurofins Product Testing Italy S.r.l., and Eurofins Product Testing Italy S.r.l.

    Aptissen SA

    Manufacturer
    🇨🇭 Switzerland·4 Basic UDI-DIs·4 Devices·2 Importers·Kiwa Belgelendirme Hizmetleri A.Ş., SGS Belgium NV, SGS Belgium NV, and Kiwa Belgelendirme Hizmetleri A.Ş.

    Atesos medical AG

    Manufacturer
    🇨🇭 Switzerland·192 Basic UDI-DIs·192 Devices·Schweizerische Vereinigung für Qualitäts- und Managementsysteme, Schweizerische Vereinigung für Qualitäts- und Managementsysteme, Schweizerische Vereinigung für Qualitäts- und Managementsysteme, and Schweizerische Vereinigung für Qualitäts- und Managementsysteme

    Rontis Corporation SA

    Manufacturer
    🇨🇭 Switzerland·225 Basic UDI-DIs·443 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and TUV NORD Polska Sp. z o.o

    Regen Lab SA

    Manufacturer
    🇨🇭 Switzerland·41 Basic UDI-DIs·41 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

    MDT Int'l SA

    Manufacturer
    🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification B.V.

    41medical AG

    Manufacturer
    🇨🇭 Switzerland·6 Basic UDI-DIs·9 Devices·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

    Assut Medical Sàrl

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·2 Importers·DEKRA Certification B.V. and DEKRA Certification B.V.

    Laboratories Hyamed SA

    Manufacturer
    🇨🇭 Switzerland·3 Basic UDI-DIs·3 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Keri Medical SA

    Manufacturer
    🇨🇭 Switzerland·13 Basic UDI-DIs·15 Devices·Schweizerische Vereinigung für Qualitäts- und Managementsysteme and Schweizerische Vereinigung für Qualitäts- und Managementsysteme

    X-os S.A.

    Manufacturer
    🇨🇭 Switzerland·115 Basic UDI-DIs·115 Devices·SGS Belgium NV and SGS Belgium NV

    Ardo medical AG

    Manufacturer
    🇨🇭 Switzerland·102 Basic UDI-DIs·106 Devices·6 Importers·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH