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Mallinckrodt Manufacturing, LLC

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories1
Latest FDA decision2025-01-03
TypeNumberDevice NameCodeDateActions
510(k) K242578 EVOLVE Nitric Oxide Delivery SystemMRN2025-01-03 View
510(k) K222930 Evolve Nitric Oxide Delivery SystemMRN2023-12-06 View
510(k) K211153 Inomax DSIRMRN2023-04-20 View
510(k) K200389 INOmax DSIR PlusMRN2020-06-17 View