3 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
FDA Enforcement
Class II
·Ongoing·Contamac Solutions, Inc.·June 18, 2025
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