Epic Medical Pte. , Ltd. - FDA 510(k) Cleared Devices

Cleared Dec 05, 2025

ProSeal™ Transfer Injector (421120, 421130, 421140)

K251722 · ONB

General Hospital · 184d

Cleared Aug 29, 2025

EZ™ IV Administration Set

K251814 · FPA

General Hospital · 77d

Cleared Aug 01, 2025

eZSURE™ Empty Fluid Container

K252094 · KPE

General Hospital · 29d

Cleared May 29, 2025

ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

K251340 · ONB

General Hospital · 29d

Cleared Jan 22, 2025

ZeroClear™ Bag Access (423100)

K243976 · ONB

General Hospital · 30d

Cleared Dec 26, 2024

ProSeal™ Vented Universal Vial Adaptor

K240517 · ONB

General Hospital · 307d

Cleared Oct 23, 2024

ProSeal™ Closed System Bag Access

K241988 · ONB

General Hospital · 107d

Cleared Oct 10, 2024

ProSeal™ In Line Pump Set (423850)

K241735 · ONB

General Hospital · 115d

Cleared Oct 07, 2024

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

K242152 · MEB

General Hospital · 76d

Cleared Aug 30, 2024

ToxiSeal™ Vial Adaptor

K241823 · ONB

General Hospital · 67d

Cleared Jun 21, 2024

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site

K241442 · KPE

General Hospital · 30d

Cleared Jun 21, 2024

ToxiSeal™ Vial Adaptor with External Flip Balloon

K241476 · ONB

General Hospital · 28d