Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Bios S.r.l. with 15 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 30, 2024: Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 30, 2024 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)K243445 · GEX | 510(k) clearances |
| Jun 14, 2024 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)K241407 · GEX | 510(k) clearances |
| Oct 30, 2023 | NuEra Tight RF Model OptiStreamK230755 · PBX | 510(k) clearances |
| Aug 11, 2023 | NuEra Tight RF FamilyK223856 · GEI | 510(k) clearances |
| May 2, 2023 | NuEra Tight RF Model APMD145.M70-USK223907 · PBX | 510(k) clearances |
| Apr 21, 2021 | NuEra Tight RF, NuEra Tight RF PlusK210867 · PBX | 510(k) clearances |
| Dec 31, 2020 | NuEra Tight Family, EMS ModelK201239 · NGX | 510(k) clearances |
| Aug 11, 2020 | NuEra Tight, NuEra Tight EMSK200359 · PBX | 510(k) clearances |
| Jul 13, 2017 | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditiClass II · In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
