BEUDAMED
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    GRAFTYS HBS

    Device
    EU MDD · Eu Md Class 3 ·Graftys·On the market·1 country

    GRAFTYS HBS

    Device
    EU MDD · Eu Md Class 3 ·Graftys·On the market·1 country

    GRAFTYS HBS

    Device
    EU MDD · Eu Md Class 3 ·Graftys·On the market·1 country

    GRAFTYS HBS

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Graftys·1 device

    GRAFTYS HBS

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Graftys·1 device

    GRAFTYS HBS

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Graftys·1 device

    Liquide fixateur Fixall-his RS

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

    FDA Enforcement
    Class II ·Ongoing·Clariance-SAS·April 22, 2026