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Bios S.R.L.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories4
Latest Approval2024-12-30
TypeNumberDevice NameCodeDate
510(k) K243445 Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) GEX 2024-12-30 View
510(k) K241407 Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) GEX 2024-06-14 View
510(k) K230755 NuEra Tight RF Model OptiStream PBX 2023-10-30 View
510(k) K223856 NuEra Tight RF Family GEI 2023-08-11 View
510(k) K223907 NuEra Tight RF Model APMD145.M70-US PBX 2023-05-02 View
510(k) K210867 NuEra Tight RF, NuEra Tight RF Plus PBX 2021-04-21 View
510(k) K201239 NuEra Tight Family, EMS Model NGX 2020-12-31 View
510(k) K200359 NuEra Tight, NuEra Tight EMS PBX 2020-08-11 View
510(k) K161632 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) GEX 2016-12-08 View
510(k) K153229 Superbium GEX 2016-04-12 View