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SONEX HEALTH LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1387-2022Class IISX-One MicroKnifeJune 29, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K252594UltraGuideCTR® image guided soft tissue release systemSeptember 29, 2025
K192873SX-One MicroKnifeDecember 20, 2019