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Epic Medical Pte. , Ltd. FDA Approvals

0 new drug approvals and 20 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
ADRx™ Admixture Device510(k)Jun 12, 2026General Hospital
SMARTeZ™ Elastomeric Infusion Pump (RS series)510(k)Apr 24, 2026General Hospital
ProSeal™ Transfer Injector (421120, 421130, 421140)510(k)Dec 5, 2025General Hospital
EZ™ IV Administration Set510(k)Aug 29, 2025General Hospital
eZSURE™ Empty Fluid Container510(k)Aug 1, 2025General Hospital
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)510(k)May 29, 2025General Hospital
ZeroClear™ Bag Access (423100)510(k)Jan 22, 2025General Hospital
ProSeal™ Vented Universal Vial Adaptor510(k)Dec 26, 2024General Hospital
ProSeal™ Closed System Bag Access510(k)Oct 23, 2024General Hospital
ProSeal™ In Line Pump Set (423850)510(k)Oct 10, 2024General Hospital
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)510(k)Oct 7, 2024General Hospital
ToxiSeal™ Vial Adaptor510(k)Aug 30, 2024General Hospital
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site510(k)Jun 21, 2024General Hospital
ToxiSeal™ Vial Adaptor with External Flip Balloon510(k)Jun 21, 2024General Hospital
ProSeal™ Injection Site Extended Male Luer Lock (422140)510(k)May 21, 2024General Hospital
ProSeal™ Injector Plus (Model no. 421050)510(k)Mar 28, 2024General Hospital
ToxiSeal Vial Adapter with External Balloon510(k)Jan 11, 2024General Hospital
ProSeal™ Closed System Administration Set510(k)Nov 3, 2023General Hospital
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)510(k)Sep 1, 2023General Hospital
Safety Subcutaneous Infusion Set510(k)Mar 24, 2021General Hospital

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