Data / Medical devices / X-Ray, Tomography, Computed, Dental / Italy
FDA-registered makers of X-Ray, Tomography, Computed, Dental in Italy: 5 establishments
5 establishments in Italy are registered with the FDA to make X-Ray, Tomography, Computed, Dental (product code OAS). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- X-Ray, Tomography, Computed, Dental
- Product code
- OAS
- Country
- Italy
Makers of X-Ray, Tomography, Computed, Dental in Italy
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cefla S.C. | IMOLA Bologna, Italy | Manufacturer | 4 | March 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| De Gotzen S.R.L. | FAGNANO OLONA Varese, Italy | Manufacturer | 1 | November 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Imaginalis S.r.l. | Sesto Fiorentino Firenze, Italy | Complaint file establishment, Manufacturer | 1 | September 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| Trident SRL | Castenedolo Brescia, Italy | Manufacturer | 1 | July 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Xline SRL | ASSAGO Milano, Italy | Complaint file establishment, Manufacturer | 1 | March 2, 2022 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.