BEUDAMED
    3 results · 10ms · Sources: EU EUDAMED, US FDA

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    cobas e801 Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022

    DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·September 29, 2021

    GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023