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

FDA Regulatory Profile

Repro-Medical System, Inc., Dba Koru Medical Systems has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Apr 29, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K214045FreedomEdge Syringe Infusion SystemApr 29, 2022
K211206FreedomEdge(R) Syringe Infusion SystemNov 9, 2021