Fidia Farmaceutici S.P.A.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Fidia Farmaceutici S.P.A.” (first 2010, latest 2020), plus 2 PMA decisions, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 152 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 152 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 265 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fidia Farmaceutici S.P.A. took a median 265 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUC | Lubricant, Personal | 3 | 3 |
| MOZ | Acid, Hyaluronic, Intraarticular | 2 | 0 |
Review panels
Most recent Fidia Farmaceutici S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191052 | HyaloGYN Vaginal Moisturizing Suppositories | NUC | 2020-01-09 | 265 |
| K150883 | HyaloGYN Vaginal Hydrating Gel | NUC | 2015-09-01 | 152 |
| K094039 | HYALO GYN | NUC | 2010-05-07 | 128 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180040 | PMA | TRILURON | 2019-03-26 |
| P950027 | PMA | HYALGAN(R) | 1997-05-28 |
Recalls
openFDA lists no recalls under a recalling firm named Fidia Farmaceutici S.P.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Fidia Farmaceutici S.P.A. is the lead sponsor of 13 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07431385: Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment (Recruiting, started 2025-09-17)
- NCT06922136: Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors (Active not recruiting, started 2024-08-01)
- NCT07520708: Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis (Active not recruiting, started 2024-07-12)
- NCT06108999: Management of Acute and Chronic Wounds With Hyaluronic Acid (Recruiting, started 2022-07-29)
- NCT06062771: Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery (Completed, started 2022-07-23)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fidia Pharmaceutical Corp. (10 510(k)s)
- Fidia Advanced Biopolymers Srl (4 510(k)s)
- Fidia Farmaceutici (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fidia Farmaceutici S.P.A.?
FDA lists 3 510(k) clearances under the applicant name “Fidia Farmaceutici S.P.A.” (first 2010, latest 2020), plus 2 PMA decisions, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fidia Farmaceutici S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fidia Farmaceutici S.P.A. is 152 days.
Which FDA product codes appear under Fidia Farmaceutici S.P.A.?
The most frequent FDA product codes under this applicant name are NUC (Lubricant, Personal, 3); MOZ (Acid, Hyaluronic, Intraarticular, 2).
Next steps
- See all 3 Fidia Farmaceutici S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code NUC, Fidia Farmaceutici S.P.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.