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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: K192659
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Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 X... 2 03/10/2021 Insulet Corporation
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001... 2 05/29/2020 Insulet Corporation
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D0... 2 05/29/2020 Insulet Corporation
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1... 2 03/20/2020 Insulet Corporation
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