Repro-Medical System, Inc., Dba Koru Medical Systems FDA Approvals

0 new drug approvals and 2 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	What it is	Route	Decided
FreedomEdge Syringe Infusion System510(k)Apr 29, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 29, 2022
FreedomEdge(R) Syringe Infusion System510(k)Nov 9, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Nov 9, 2021