Data / Medical devices / Needle, Hypodermic, Single Lumen / Italy
FDA-registered makers of Needle, Hypodermic, Single Lumen in Italy: 5 establishments
5 establishments in Italy are registered with the FDA to make Needle, Hypodermic, Single Lumen (product code FMI). 3 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
- Needle, Hypodermic, Single Lumen
- Product code
- FMI
- Country
- Italy
Makers of Needle, Hypodermic, Single Lumen in Italy
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| PIKDARE S.p.A. | Casnate con Bernate Como, Italy | Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer | 4 | January 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ri.mos. SRL | MIRANDOLA (MO) Modena, Italy | Manufacturer | 2 | October 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Meus SRL | Piove di Sacco Padova, Italy | Manufacturer | 1 | December 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| M.V. S.R.L. | Gonzaga Mantova, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roncadelle Operations SRL | Castel Mella Brescia, Italy | Manufacturer | 0 | 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.