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

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

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·March 26, 2025

    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·September 30, 2020

    Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

    FDA Enforcement
    Class II ·Ongoing·Synthes USA HQ, Inc.·August 7, 2013

    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Corp. Hq.)·October 2, 2024