BEUDAMED
    12 results · 31ms · Sources: EU EUDAMED, US FDA

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    ACTIVE-IMPLANTABLE DEVICES - OTHER

    Device
    EU MDD · Eu Md Class 3 ·MagForce NT GmbH·On the market·2 countries

    Mars Medical

    Authorized representative
    🇩🇪 Germany·14 Manufacturers·71 Devices

    Arazy Group GmbH

    Authorized representative
    🇩🇪 Germany·30 Manufacturers·739 Devices

    MedNet EC-REP IIb GmbH

    Authorized representative
    🇩🇪 Germany·32 Manufacturers·165 Devices

    BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019

    BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019

    Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 24, 2024

    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

    FDA Enforcement
    Class II ·Terminated·Oculus Optikgeraete GMBH·February 28, 2018

    Europecert UG (haftungsbeschränkt)

    Authorized representative
    🇩🇪 Germany·48 Manufacturers·2024 Devices

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    mdi Europa GmbH

    Authorized representative
    🇩🇪 Germany·132 Manufacturers·4741 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices