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Brainsway , Ltd.

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

Total Devices10
Categories3
Latest FDA decision2025-11-07
TypeNumberDevice NameCodeDateActions
510(k) K251391 BrainsWay Deep TMS SystemOBP2025-11-07 View
510(k) K251449 BrainsWay Deep TMS SystemOBP2025-09-13 View
510(k) K222196 Deep TMS SystemOBP2024-05-31 View
510(k) K220819 BrainsWay Deep TMS SystemOBP2022-08-26 View
510(k) K210201 Deep Transcranial Magnetic Stimulation (DTMS) SystemOBP2021-08-17 View
510(k) K203735 Brainsway Deep TMS SystemOBP2021-04-23 View
510(k) K203616 Brainsway Deep (DTMS) SystemQMD2021-04-16 View
510(k) K200957 Brainsway Deep TMS SystemQMD2020-08-21 View
510(k) K183303 Brainsway Deep TMS SystemQCI2019-03-08 View
510(k) K173540 Brainsway Deep (DTMS) SystemOBP2018-05-03 View

Related Clinical Trials

NCT07216872Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)RECRUITINGNCT07706790Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimualtion (rfTMS) in Healthy AdultsCOMPLETEDNCT07770555Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use DisorderNOT_YET_RECRUITING
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