BEUDAMED
    2 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007

    FDA Enforcement
    Class II ·Ongoing·Mallinckrodt, LLC.·September 21, 2022

    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.

    FDA Enforcement
    Class II ·Terminated·Mallinckrodt Manufacturing LLC·July 12, 2017