BEUDAMED
    6 results · 7ms · Sources: EU EUDAMED, US FDA

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

    BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200

    FDA Enforcement
    Class III ·Ongoing·Becton Dickinson & Company·March 2, 2022

    Akreos, SKU: AO60P0300. Akreos intraocular lenses

    FDA Enforcement
    Class III ·Ongoing·Bausch & Lomb Surgical, Inc.·September 3, 2025

    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

    FDA Enforcement
    Class III ·Ongoing·Owens & Minor Distribution, Inc.·February 15, 2023

    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095

    FDA Enforcement
    Class III ·Ongoing·R & D Systems, Inc.·July 27, 2022

    abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089

    FDA Enforcement
    Class III ·Ongoing·S & MOHR AMERICA, S.A. DE C.V.·March 1, 2023

    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

    FDA Enforcement
    Class III ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·April 3, 2019