Brainsway , Ltd.
Brainsway , Ltd. appears in FDA public data with 0 recalls, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 7, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251391 | BrainsWay Deep TMS System | November 7, 2025 |
| K251449 | BrainsWay Deep TMS System | September 13, 2025 |
| K222196 | Deep TMS System | May 31, 2024 |
| K220819 | BrainsWay Deep TMS System | August 26, 2022 |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | August 17, 2021 |
| K203735 | Brainsway Deep TMS System | April 23, 2021 |
| K203616 | Brainsway Deep (DTMS) System | April 16, 2021 |
| K200957 | Brainsway Deep TMS System | August 21, 2020 |
| K183303 | Brainsway Deep TMS System | March 8, 2019 |
| K173540 | Brainsway Deep (DTMS) System | May 3, 2018 |
| K122288 | BRAINSWAY DEEP TMS SYSTEM | January 7, 2013 |