Medical Device Manufacturer · SG , Singapore

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

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

FDA 510(k) cleared devices by Epic Medical Pte. , Ltd. General Hospital

20 devices
1-20 of 20
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
Cleared May 21, 2024
ProSeal™ Injection Site Extended Male Luer Lock (422140)
K240433 · ONB
General Hospital · 97d
Cleared Mar 28, 2024
ProSeal™ Injector Plus (Model no. 421050)
K240171 · ONB
General Hospital · 66d
Cleared Jan 11, 2024
ToxiSeal Vial Adapter with External Balloon
K222929 · ONB
General Hospital · 472d
Cleared Nov 03, 2023
ProSeal™ Closed System Administration Set
K230343 · FPA
General Hospital · 268d
Cleared Sep 01, 2023
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
K223674 · KPE
General Hospital · 268d
Cleared Mar 24, 2021
Safety Subcutaneous Infusion Set
K201626 · FPA
General Hospital · 281d
Cleared Aug 07, 2020
ProSeal™ Closed System drug Transfer Device (CSTD)
K192075 · ONB
General Hospital · 371d
Cleared Apr 04, 2016
SMARTez elastomeric infusion pump
K151650 · MEB
General Hospital · 291d
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