FDA applicant
Audio Technologies S.R.L.
FDA records 2 decisions for Audio Technologies S.R.L. (Piacenza, IT) from 2000 to 2009: 2 510(k) clearances. Most are in product codes ETA (Replacement, Ossicular Prosthesis, Total) and ETB (Prosthesis, Partial Ossicular Replacement). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Audio Technologies S.R.L.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Audio Technologies S.R.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Audio”
FDA records each applicant name separately; these may or may not be the same firm.