device 510k
saveTandem Diabetes Care — SteadiSet infusion set (510k cleared)
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Product code: FPA. Advisory committee: General Hospital. Type: Abbreviated
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same company · ±60 days · 6
- device recallTandem Diabetes Care, Inc. device recall (Cls II)Aug 5, 2025
- device recallTandem Diabetes Care, Inc. device recall (Cls I)Jul 21, 2025
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- device pmaAbbott Diabetes Care, Inc. — FreeStyle Libre 14-Day Flash Glucose Monitoring System (PMA supplement)Jul 11, 2025
- device recallTandem Diabetes Care, Inc. device recall (Cls II)Jul 3, 2025
- device 510kTandem Diabetes Care, Inc. — t:slim X2 insulin pump with interoperable technology (510k cleared)Sep 24, 2025
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