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

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·January 21, 2015

    MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·September 14, 2016

    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·August 10, 2016

    MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·September 14, 2016

    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·September 10, 2014

    Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·May 17, 2017

    CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·September 21, 2016

    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·September 21, 2016