Channel Medsystems, Inc.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1584-2025Class IIBrand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/CaMarch 20, 2025
Z-1889-2024Class IIBrand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/CaMay 3, 2024