BEUDAMED
    3 results · 21ms · Sources: EU EUDAMED, US FDA

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

    BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·May 20, 2020

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·October 18, 2023

    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