Unetixs Vascular, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
6
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1196-2023Class IIMultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01February 10, 2023
Z-1194-2023Class IIMultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01February 10, 2023
Z-1195-2023Class IIMultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01February 10, 2023
Z-1193-2023Class IIMultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-000February 10, 2023