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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 4 of 4 Results
510(K) Number: K131686
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Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classif... 2 08/08/2018 INO therapeutics LLC/dba ikaria
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitri... 2 01/23/2017 INO Therapeutics (dba Ikaria)
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nit... 2 12/12/2014 INO Therapeutics (dba Ikaria)
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS ... 2 05/02/2014 INO Therapeutics (dba Ikaria)
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