Bio-Signal Group Corp.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0705-2020Class IIHydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: October 29, 2019
Z-0704-2020Class IIHydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with October 29, 2019