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

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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    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

    smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD Inc.·October 10, 2018

    smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD Inc.·October 10, 2018

    smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD Inc.·October 10, 2018

    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

    FDA Enforcement
    Class III ·Terminated·Advanced Bionics, LLC·February 26, 2020