Medical Device Manufacturer · SG , Singapore

Epic Medical Pte. , Ltd.

20 submissions · 20 cleared · Since 2016
20
Total
20
Cleared
0
Denied

Epic Medical Pte. , Ltd. — FDA 510(k) Submissions

Epic Medical Pte. , Ltd. has submitted 20 FDA 510(k) premarket notifications since 2016, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, Set, Administration, Intravascular, Container, I.v., Pump, Infusion, Elastomeric . Use the specialty filter in the sidebar to narrow results.

20 devices
1–12 of 20
ProSeal? Transfer Injector (421120, 421130, 421140)
K251722 · ONB Closed Antineoplastic And... · General Hospital
Dec 2025 184d
EZ? IV Administration Set
K251814 · FPA Set, Administration,... · General Hospital
Aug 2025 77d
eZSURE? Empty Fluid Container
K252094 · KPE Container, I.v. · General Hospital
Aug 2025 29d
ProSeal? Bag Spike with Additive Port (423370ST, 423370)
K251340 · ONB Closed Antineoplastic And... · General Hospital
May 2025 29d
ZeroClear? Bag Access (423100)
K243976 · ONB Closed Antineoplastic And... · General Hospital
Jan 2025 30d
ProSeal? Vented Universal Vial Adaptor
K240517 · ONB Closed Antineoplastic And... · General Hospital
Dec 2024 307d
ProSeal? Closed System Bag Access
K241988 · ONB Closed Antineoplastic And... · General Hospital
Oct 2024 107d
ProSeal? In Line Pump Set (423850)
K241735 · ONB Closed Antineoplastic And... · General Hospital
Oct 2024 115d
SMARTeZ? Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · MEB Pump, Infusion, Elastomeric · General Hospital
Oct 2024 76d
ToxiSeal? Vial Adaptor
K241823 · ONB Closed Antineoplastic And... · General Hospital
Aug 2024 67d
eZSURE? Empty Fluid Container with ProSeal? Injection Site
K241442 · KPE Container, I.v. · General Hospital
Jun 2024 30d
ToxiSeal? Vial Adaptor with External Flip Balloon
K241476 · ONB Closed Antineoplastic And... · General Hospital
Jun 2024 28d
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