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Fona S.R.L

FDA Regulatory Profile

Fona S.R.L has 0 FDA recalls, 2 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 19, 2023 · OAI
Latest 510(k)
Aug 23, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 19, 2023Assago, ItalyDevicesOfficial Action Indicated (OAI)3003528079
Sep 11, 2009Assago, ItalyDevicesVoluntary Action Indicated (VAI)3003528079

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K222274FONA XDCAug 23, 2022
K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephMar 2, 2022
K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2Aug 30, 2021
K161131FONA Pan/CephNov 3, 2016

FDA data resources