BEUDAMED
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    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·June 24, 2026

    Dr. Ihde Dental AG

    Manufacturer
    🇨🇭 Switzerland

    Simpladent GmbH

    Manufacturer
    🇨🇭 Switzerland

    Polydentia SA

    Manufacturer
    🇨🇭 Switzerland·38 Basic UDI-DIs·385 Devices·9 Importers·SGS Belgium NV

    Precimatrix Cunei Legno

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    Precimatrix Cunei Legno

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    Precimatrix Cunei Legno

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    Precimatrix Cunei Legno

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    Simplee Premolar Sectional Matrix Bands

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    Simplee Molar Sectional Matrix Bands

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    NiTi Ring

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    orange wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    orange wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    pinky wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market

    orange wood wedges

    Device
    EU MDR · Eu Md Class 1 ·Polydentia SA·On the market