Data / Medical devices / Italy / Fidia Farmaceutici SPA
Fidia Farmaceutici SPA: FDA-registered device maker in ABANO TERME Padova, Italy, 4 510(k) clearances and 3 PMA approvals
Fidia Farmaceutici SPA is registered with the FDA (registration 9610200) in ABANO TERME Padova, Italy. It lists 4 device types. The FDA files 4 510(k) clearances and 3 PMA approvals under its listings, the newest dated January 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610200
- FEI number
- 3002806986
- Address
- Via Ponte Della Fabbrica 3/A, ABANO TERME Padova, Italy, 35031
- Owner or operator
- Fidia Farmaceutici SPA (9027294)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- Hyalgan, Hyalo GYN, Hyalo GYN Vaginal Moisturizing Suppositories, Hyalo4 Care Clear Hydrogel, Hyalo4 Care Hydrogel, Hymovis, Hymovis One, RICHPLAT ORTHO 20 PRP System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Hyaluronic, Intraarticular | MOZ | 3 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2020 | K191052 | HyaloGYN Vaginal Moisturizing Suppositories | NUC | Substantially Equivalent | Fidia Farmaceutici S.P.A. | accessdata.fda.gov |
| September 1, 2015 | K150883 | HyaloGYN Vaginal Hydrating Gel | NUC | Substantially Equivalent | Fidia Farmaceutici S.P.A. | accessdata.fda.gov |
| September 22, 1998 | K973725 | BIONECT CLEAR HYDROGEL | MGQ | Substantially Equivalent | Fidia Pharmaceutical Corp. | accessdata.fda.gov |
| February 12, 1997 | K963004 | BIONECT CREAM | MGQ | Substantially Equivalent for Some Indications | Fidia Pharmaceutical Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 26, 2019 | P180040 | TRILURON | MOZ | 4 | June 28, 2024 | accessdata.fda.gov |
| August 28, 2015 | P150010 | HYMOVIS | MOZ | 5 | April 9, 2025 | accessdata.fda.gov |
| May 28, 1997 | P950027 | HYALGAN(R) | MOZ | 15 | June 28, 2024 | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Personal
- All makers of Acid, Hyaluronic, Intraarticular
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Updated June 28, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.