BEUDAMED
    6 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 28, 2018

    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 28, 2018

    HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·December 8, 2021

    Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·July 13, 2022

    Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 3, 2020

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023