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PATH

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0940-2026Class IIMADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)November 6, 2025
Z-0403-2024Class IIAuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 10009September 26, 2023
Z-0401-2024Class IISENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 10009September 26, 2023
Z-0404-2024Class IISENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part NuSeptember 26, 2023
Z-0402-2024Class IISENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part NSeptember 26, 2023