Epic Medical Pte. , Ltd.
FDA 510(k) & PMA Approved Devices — 21 products
Total Devices21
Categories4
Latest Approval2026-04-24
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | MEB | 2026-04-24 | View |
| 510(k) | K251722 | ProSeal Transfer Injector (421120, 421130, 421140) | ONB | 2025-12-05 | View |
| 510(k) | K251814 | EZ IV Administration Set | FPA | 2025-08-29 | View |
| 510(k) | K252094 | eZSURE Empty Fluid Container | KPE | 2025-08-01 | View |
| 510(k) | K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | ONB | 2025-05-29 | View |
| 510(k) | K243976 | ZeroClear Bag Access (423100) | ONB | 2025-01-22 | View |
| 510(k) | K240517 | ProSeal Vented Universal Vial Adaptor | ONB | 2024-12-26 | View |
| 510(k) | K241988 | ProSeal Closed System Bag Access | ONB | 2024-10-23 | View |
| 510(k) | K241735 | ProSeal In Line Pump Set (423850) | ONB | 2024-10-10 | View |
| 510(k) | K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | MEB | 2024-10-07 | View |
| 510(k) | K241823 | ToxiSeal Vial Adaptor | ONB | 2024-08-30 | View |
| 510(k) | K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site | KPE | 2024-06-21 | View |
| 510(k) | K241476 | ToxiSeal Vial Adaptor with External Flip Balloon | ONB | 2024-06-21 | View |
| 510(k) | K240433 | ProSeal Injection Site Extended Male Luer Lock (422140) | ONB | 2024-05-21 | View |
| 510(k) | K240171 | ProSeal Injector Plus (Model no. 421050) | ONB | 2024-03-28 | View |
| 510(k) | K222929 | ToxiSeal Vial Adapter with External Balloon | ONB | 2024-01-11 | View |
| 510(k) | K230343 | ProSeal Closed System Administration Set | FPA | 2023-11-03 | View |
| 510(k) | K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) | KPE | 2023-09-01 | View |
| 510(k) | K201626 | Safety Subcutaneous Infusion Set | FPA | 2021-03-24 | View |
| 510(k) | K192075 | ProSeal Closed System drug Transfer Device (CSTD) | ONB | 2020-08-07 | View |
| 510(k) | K151650 | SMARTez elastomeric infusion pump | MEB | 2016-04-04 | View |
No matching devices.