Data / Medical devices / Italy / Gilardoni S.P.A.
Gilardoni S.P.A.: FDA-registered device maker in MANDELLO DEL LARIO Lecco, Italy, 1 510(k) clearance
Gilardoni S.P.A. is registered with the FDA (registration 8043725) in MANDELLO DEL LARIO Lecco, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043725
- FEI number
- 3009631751
- Address
- Via Arturo Gilardoni, 1, MANDELLO DEL LARIO Lecco, Italy, 23826
- Owner or operator
- GILARDONI S.p.A. (9003480)
- Roles
- Manufacturer
- First device listed
- November 20, 1997
- Registered through
- 2026
- Brand names listed
- IXION III HF GENERATOR, IXION MONOBLOCK, RADGIL2 US
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Manufacturer | accessdata.fda.gov |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Manufacturer | accessdata.fda.gov |
| Irradiator, Blood To Prevent Graft Versus Host Disease | MOT | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 17, 2020 | K201177 | RadGil2 | MOT | Substantially Equivalent | R3 X-Ray L.L.C | accessdata.fda.gov |
Compare with other makers
- All makers of Assembly, Tube Housing, X-Ray, Diagnostic
- All makers of Generator, High-Voltage, X-Ray, Diagnostic
- All makers of Irradiator, Blood To Prevent Graft Versus Host Disease
Updated August 17, 2020. 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.