FDA applicant
De Gotzen S.R.L.
FDA records 7 decisions for De Gotzen S.R.L. (Olgiate Olona, IT) from 2014 to 2023: 7 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and EHD (Unit, X-Ray, Extraoral With Timer). Since 2016 its 510(k)s took a median of 213 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “De Götzen S.R.L.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided De Gotzen S.R.L.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like De Gotzen 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