BEUDAMED
    395 results · 13ms · Sources: EU EUDAMED, US FDA

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    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·March 21, 2018

    AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·March 29, 2017

    4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·December 4, 2019

    AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·December 28, 2016

    CVC Tray Pediatrics. Product Code: AMS-9335CP-2.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018

    19Ga x 1 Huber Needle Set. Product Code: MBS-1910.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018

    20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018

    Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018

    3-Way Standardbore Stopcock. Product Code: AMS-100.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018

    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 STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model¿ SL Rotational and Hinge Knee Prostheses) 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 STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·December 7, 2018

    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 Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code MEH·December 4, 2018

    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 Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code MEH·December 4, 2018