Ivenix, Inc.

FDA Regulatory Profile

Ivenix, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1381-2022, Class II) was initiated on April 22, 2022. Its most recent 510(k) clearance was granted on November 10, 2021.

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