FDA applicant
Inventis S.R.L.
FDA records 2 decisions for Inventis S.R.L. (Padova, IT) from 2014 to 2025: 2 510(k) clearances. Most are in product codes GWN (Nystagmograph) and ETY (Tester, Auditory Impedance). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Inventis S.R.L.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2014high 1 (2014) · low 0 (2015)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Inventis 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) Report