5 results
·
8ms
·
Sources: EU EUDAMED, US FDA
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Enforcement
Class II
·Ongoing·PATH·December 24, 2025
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023