Epic Medical Pte. , Ltd.
FDA 510(k) & PMA Approved 기기 — 22 products
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총 기기 수22
카테고리0
최신 FDA 결정
| 유형 | 번호 | 기기명 | 코드 | 날짜 | 작업 |
|---|---|---|---|---|---|
| 510(k) | K252987 | ADRx® Admixture Device | LHI | 2026-06-12 | 보기 |
| 510(k) | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | MEB | 2026-04-24 | 보기 |
| 510(k) | K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) | ONB | 2025-12-05 | 보기 |
| 510(k) | K251814 | EZ™ IV Administration Set | FPA | 2025-08-29 | 보기 |
| 510(k) | K252094 | eZSURE™ Empty Fluid Container | KPE | 2025-08-01 | 보기 |
| 510(k) | K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | ONB | 2025-05-29 | 보기 |
| 510(k) | K243976 | ZeroClear™ Bag Access (423100) | ONB | 2025-01-22 | 보기 |
| 510(k) | K240517 | ProSeal™ Vented Universal Vial Adaptor | ONB | 2024-12-26 | 보기 |
| 510(k) | K241988 | ProSeal™ Closed System Bag Access | ONB | 2024-10-23 | 보기 |
| 510(k) | K241735 | ProSeal™ In Line Pump Set (423850) | ONB | 2024-10-10 | 보기 |
| 510(k) | K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | MEB | 2024-10-07 | 보기 |
| 510(k) | K241823 | ToxiSeal™ Vial Adaptor | ONB | 2024-08-30 | 보기 |
| 510(k) | K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | KPE | 2024-06-21 | 보기 |
| 510(k) | K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | ONB | 2024-06-21 | 보기 |
| 510(k) | K240433 | ProSeal™ Injection Site Extended Male Luer Lock (422140) | ONB | 2024-05-21 | 보기 |
| 510(k) | K240171 | ProSeal™ Injector Plus (Model no. 421050) | ONB | 2024-03-28 | 보기 |
| 510(k) | K222929 | ToxiSeal Vial Adapter with External Balloon | ONB | 2024-01-11 | 보기 |
| 510(k) | K230343 | ProSeal™ Closed System Administration Set | FPA | 2023-11-03 | 보기 |
| 510(k) | K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | KPE | 2023-09-01 | 보기 |
| 510(k) | K201626 | Safety Subcutaneous Infusion Set | FPA | 2021-03-24 | 보기 |
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