Atlas FDA

PATH

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) recall (Z-0940-2026)PATH2025-12-18
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Nu recall (Z-0401-2024)PATH2023-11-25
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH1000 recall (Z-0402-2024)PATH2023-11-25
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Nu recall (Z-0403-2024)PATH2023-11-25
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH10009 recall (Z-0404-2024)PATH2023-11-25

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Every clearance here is in the API, with alerts when new ones post.