Data / Medical devices / System, X-Ray, Extraoral Source, Digital / Italy
FDA-registered makers of System, X-Ray, Extraoral Source, Digital in Italy: 5 establishments
5 establishments in Italy are registered with the FDA to make System, X-Ray, Extraoral Source, Digital (product code MUH). 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
- System, X-Ray, Extraoral Source, Digital
- Product code
- MUH
- Country
- Italy
Makers of System, X-Ray, Extraoral Source, Digital in Italy
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Trident SRL | Castenedolo Brescia, Italy | Manufacturer, Repackager or relabeler | 4 | April 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Cefla S.C. | IMOLA Bologna, Italy | Manufacturer, Repackager or relabeler | 3 | July 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| De Gotzen S.R.L. | FAGNANO OLONA Varese, Italy | Manufacturer | 3 | February 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Xline SRL | ASSAGO Milano, Italy | Complaint file establishment, Manufacturer | 3 | August 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nical SPA | MILAN (MI) Lombardy, Italy | Manufacturer | 1 | March 18, 2015 | 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.