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DEKA Research & Development

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K261672 twiist Automated Insulin Delivery (AID) SystemQFG2026-06-17 View
510(k) K261530 iiSure Infusion SetFPA2026-06-03 View
510(k) K243841 Sparta Infusion Set for InsulinFPA2025-08-01 View
510(k) K233557 HemoCare Hemodialysis SystemKDI2024-07-12 View
510(k) K240920 HemoCare Bicarbonate Concentrate Set (BCS)KPO2024-07-12 View
510(k) K240256 Remunity SystemQJY2024-06-12 View
510(k) K241178 DEKA ACE Pump SystemQFG2024-05-24 View
510(k) K234055 DEKA LoopQJI2024-03-13 View
510(k) K233952 DEKA ACE Pump SystemQFG2024-03-13 View
510(k) K232316 DEKA Infusion System, DEKA Administration SetLDR2024-03-01 View
510(k) K213536 DEKA ACE Pump SystemQFG2023-07-25 View
510(k) K202690 Remunity Pump for Remodulin (treprostinil) InjectionQJY2020-12-30 View
510(k) K191313 Unity Subcutaneous Infusion System for RemodulinQJY2020-02-21 View
510(k) K190182 Unity Subcutaneous Delivery System for RemodulinFRN2019-05-06 View
510(k) K153760 Volumetric Infusion ControllerLDR2016-10-03 View
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