Epic Medical Pte. , Ltd. is one of 33 FDA 510(k) medical device manufacturers from Singapore in the dataset, ranked by real submission volume.
Epic Medical Pte. , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ADRx™ Admixture Device, SMARTeZ™ Elastomeric Infusion Pump (RS series), ProSeal™ Transfer Injector (421120, 421130, 421140)
22
Total
22
Cleared
0
Denied
Epic Medical Pte. , Ltd. has 22 FDA 510(k) cleared general hospital devices. Based in Singapore, SG.
Latest FDA clearance: Jun 2026. Active since 2016.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by QUARAS, LLC, Third Party Review Group, LLC and G&L Scientific, Inc..
FDA 510(k) Regulatory Record - Epic Medical Pte. , Ltd.
22 devices
Cleared
Jun 12, 2026
ADRx™ Admixture Device
General Hospital
267d
Cleared
Apr 24, 2026
SMARTeZ™ Elastomeric Infusion Pump (RS series)
General Hospital
452d
Cleared
Dec 05, 2025
ProSeal™ Transfer Injector (421120, 421130, 421140)
General Hospital
184d
Cleared
Aug 29, 2025
EZ™ IV Administration Set
General Hospital
77d
Cleared
Aug 01, 2025
eZSURE™ Empty Fluid Container
General Hospital
29d
Cleared
May 29, 2025
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
General Hospital
29d
Cleared
Jan 22, 2025
ZeroClear™ Bag Access (423100)
General Hospital
30d
Cleared
Dec 26, 2024
ProSeal™ Vented Universal Vial Adaptor
General Hospital
307d
Cleared
Oct 23, 2024
ProSeal™ Closed System Bag Access
General Hospital
107d
Cleared
Oct 10, 2024
ProSeal™ In Line Pump Set (423850)
General Hospital
115d
Cleared
Oct 07, 2024
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
General Hospital
76d
Cleared
Aug 30, 2024
ToxiSeal™ Vial Adaptor
General Hospital
67d