510(k) Report

FDA applicant

Farma-Derma S.R.L.

Sala Bolognese, IT2 decisions2016–20220 recalls

FDA records 2 decisions for Farma-Derma S.R.L. (Sala Bolognese, IT) from 2016 to 2022: 2 510(k) clearances. All are in product code NUC (Lubricant, Personal). Its devices cite 2 predicates, 1 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, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Farma-Derma S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12022: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Farma-Derma S.R.L. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Farma-Derma 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

Which product codes does it file in?

  • NUCLubricant, Personal2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213220Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 20223cite it
  • K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L. · 20161cites it

What has FDA decided for it lately?

  • K213220Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 2022
  • K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L. · 2016

All 2 as Farma-Derma S.R.L. →