Brainsway , Ltd. - FDA 510(k) Cleared Devices
11
Total
11
Cleared
0
Denied
Brainsway , Ltd. has 11 FDA 510(k) cleared neurology devices. Based in Kfar Saba, IL.
Latest FDA clearance: Nov 2025. Active since 2013.
Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by A. Stein - Regulatory Affairs Consulting , Ltd., A. Stein Regulatory Affairs Consulting , Ltd. and A. Stein-Regulatort Affairs Consulting , Ltd.. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
11 devices
Cleared
Nov 07, 2025
BrainsWay Deep TMS System
Neurology
186d
Cleared
Sep 13, 2025
BrainsWay Deep TMS System
Neurology
127d
Cleared
May 31, 2024
Deep TMS System
Neurology
679d
Cleared
CT
Aug 26, 2022
BrainsWay Deep TMS System
Neurology
158d
Cleared
Aug 17, 2021
Deep Transcranial Magnetic Stimulation (DTMS) System
Neurology
204d
Cleared
CT
Apr 23, 2021
Brainsway Deep TMS System
Neurology
123d
Cleared
Apr 16, 2021
Brainsway Deep (DTMS) System
Neurology
127d
Cleared
Aug 21, 2020
Brainsway Deep TMS System
Neurology
134d
Cleared
Mar 08, 2019
Brainsway Deep TMS System
Neurology
101d
Cleared
May 03, 2018
Brainsway Deep (DTMS) System
Neurology
169d
Cleared
Jan 07, 2013
BRAINSWAY DEEP TMS SYSTEM
Neurology
161d