BEUDAMED
    5 results · 14ms · Sources: EU EUDAMED, US FDA

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    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

    FDA Enforcement
    Class II ·Ongoing·Young Dental Manufacturing I, LLC·June 14, 2023

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    FDA Enforcement
    Class II ·Ongoing·Bayer Medical Care, Inc.·January 18, 2023

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·November 16, 2022