Data / Medical devices / Italy / Medax S.R.L. Unipersonale
Medax S.R.L. Unipersonale: FDA-registered device maker in San Possidonio Modena, Italy, 5 510(k) clearances
Medax S.R.L. Unipersonale is registered with the FDA (registration 3007648417) in San Possidonio Modena, Italy. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 2, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007648417
- Address
- Via Sandro Pertini 4, San Possidonio Modena, Italy, 41039
- Owner or operator
- Medax S.r.l. Unipersonale (10029412)
- Roles
- Manufacturer
- First device listed
- February 3, 2016
- Registered through
- 2026
- Brand names listed
- AVANGARDE, BIO-FEATHER, CAESAR, COX, FACILE, FNA CHIBA, FNA FRANSEEN, FNA WESTCOTT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle Guide Kit | OIJ | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Tumor Localization | MIJ | 1 | 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 |
|---|---|---|---|---|---|---|
| April 2, 2020 | K192101 | Medone Ultra, Medextra | KNW | Substantially Equivalent | Medax Srl Unipersonale | accessdata.fda.gov |
| April 2, 2020 | K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System | KNW | Substantially Equivalent | Medax Srl Unipersonale | accessdata.fda.gov |
| October 18, 2018 | K181803 | Medax Biopsy Systems III | KNW | Substantially Equivalent | Medax Srl Unipersonale | accessdata.fda.gov |
| November 13, 2017 | K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | KNW | Substantially Equivalent | Medax Srl Unipersonale | accessdata.fda.gov |
| December 22, 2015 | K142125 | New Medax Biopsy Systems | KNW | Substantially Equivalent | Medax Srl Unipersonale | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Biopsy
- All makers of Biopsy Needle Guide Kit
- All makers of Needle, Tumor Localization
Updated April 2, 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.