Epic Medical Pte. , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Known Names

epic medical pte, epic medical pte.

Recent 510(k) Clearances

K-NumberDeviceDate
K251722ProSeal™ Transfer Injector (421120, 421130, 421140)December 5, 2025
K251814EZ™ IV Administration SetAugust 29, 2025
K252094eZSURE™ Empty Fluid ContainerAugust 1, 2025
K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)May 29, 2025
K243976ZeroClear™ Bag Access (423100)January 22, 2025
K240517ProSeal™ Vented Universal Vial AdaptorDecember 26, 2024
K241988ProSeal™ Closed System Bag AccessOctober 23, 2024
K241735ProSeal™ In Line Pump Set (423850)October 10, 2024
K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)October 7, 2024
K241823ToxiSeal™ Vial AdaptorAugust 30, 2024
K241476ToxiSeal™ Vial Adaptor with External Flip BalloonJune 21, 2024
K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteJune 21, 2024
K240433ProSeal™ Injection Site Extended Male Luer Lock (422140)May 21, 2024
K240171ProSeal™ Injector Plus (Model no. 421050)March 28, 2024
K222929ToxiSeal Vial Adapter with External BalloonJanuary 11, 2024
K230343ProSeal™ Closed System Administration SetNovember 3, 2023
K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)September 1, 2023
K201626Safety Subcutaneous Infusion SetMarch 24, 2021
K192075ProSeal™ Closed System drug Transfer Device (CSTD)August 7, 2020
K151650SMARTez elastomeric infusion pumpApril 4, 2016