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Ivenix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1381-2022Class IIIvenix Infusion System (IIS)April 22, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorNovember 10, 2021
K183311Ivenix Infusion System (IIS)June 7, 2019