Sonesta Medical Ab

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0460-2026Class IIBrand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A August 22, 2025
Z-1894-2017Class IISonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220VMarch 8, 2017