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Soterix Medical, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories5
Latest FDA decision2026-02-20
TypeNumberDevice NameCodeDateActions
510(k) K251653 SPRY TMS Therapy System (0550)OBP2026-02-20 View
510(k) K233751 Milieve (YPS-301BD)PCC2024-06-03 View
510(k) K234080 MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF2024-03-25 View
510(k) K192823 MEGA-TMSGWF2021-08-13 View
510(k) K191422 Neural NavigatorHAW2020-04-06 View
510(k) K170291 IontoDCEGJ2017-05-01 View