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Epic Medical Pte. , Ltd.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories5
Latest FDA decision2026-06-12
TypeNumberDevice NameCodeDateActions
510(k) K252987 ADRx™ Admixture DeviceLHI2026-06-12 View
510(k) K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)MEB2026-04-24 View
510(k) K251722 ProSeal™ Transfer Injector (421120, 421130, 421140)ONB2025-12-05 View
510(k) K251814 EZ™ IV Administration SetFPA2025-08-29 View
510(k) K252094 eZSURE™ Empty Fluid ContainerKPE2025-08-01 View
510(k) K251340 ProSeal™ Bag Spike with Additive Port (423370ST, 423370)ONB2025-05-29 View
510(k) K243976 ZeroClear™ Bag Access (423100)ONB2025-01-22 View
510(k) K240517 ProSeal™ Vented Universal Vial AdaptorONB2024-12-26 View
510(k) K241988 ProSeal™ Closed System Bag AccessONB2024-10-23 View
510(k) K241735 ProSeal™ In Line Pump Set (423850)ONB2024-10-10 View
510(k) K242152 SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)MEB2024-10-07 View
510(k) K241823 ToxiSeal™ Vial AdaptorONB2024-08-30 View
510(k) K241442 eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteKPE2024-06-21 View
510(k) K241476 ToxiSeal™ Vial Adaptor with External Flip BalloonONB2024-06-21 View
510(k) K240433 ProSeal™ Injection Site Extended Male Luer Lock (422140)ONB2024-05-21 View
510(k) K240171 ProSeal™ Injector Plus (Model no. 421050)ONB2024-03-28 View
510(k) K222929 ToxiSeal Vial Adapter with External BalloonONB2024-01-11 View
510(k) K230343 ProSeal™ Closed System Administration SetFPA2023-11-03 View
510(k) K223674 eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)KPE2023-09-01 View
510(k) K201626 Safety Subcutaneous Infusion SetFPA2021-03-24 View

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