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DEKA Research & Development

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

器械总数15
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K261672 twiist Automated Insulin Delivery (AID) SystemQFG2026-06-17 查看
510(k) K261530 iiSure Infusion SetFPA2026-06-03 查看
510(k) K243841 Sparta 胰岛素输液器FPA2025-08-01 查看
510(k) K240920 HemoCare 碳酸氢钠浓缩液套装（BCS）KPO2024-07-12 查看
510(k) K233557 HemoCare 血液透析系统KDI2024-07-12 查看
510(k) K240256 Remunity 系统QJY2024-06-12 查看
510(k) K241178 DEKA ACE 泵系统QFG2024-05-24 查看
510(k) K233952 DEKA ACE 泵系统QFG2024-03-13 查看
510(k) K234055 DEKA LoopQJI2024-03-13 查看
510(k) K232316 DEKA 注射系统，DEKA 管理套装LDR2024-03-01 查看
510(k) K213536 DEKA ACE 泵系统QFG2023-07-25 查看
510(k) K202690 Remunity 泵用于Remodulin（曲前列素）注射剂QJY2020-12-30 查看
510(k) K191313 Unity Subcutaneous Infusion System for RemodulinQJY2020-02-21 查看
510(k) K190182 Unity Subcutaneous Delivery System for RemodulinFRN2019-05-06 查看
510(k) K153760 Volumetric Infusion ControllerLDR2016-10-03 查看
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