ClearanceBrief
Company ยท IL

Brainsway , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OBPTranscranial Magnetic Stimulator8
QMDTranscranial Magnetic Stimulation System For Smoking Cessation2
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 7, 2025K251391BrainsWay Deep TMS System
Brainsway , Ltd., IL
OBP
Sep 13, 2025K251449BrainsWay Deep TMS System
Brainsway , Ltd., IL
OBP
May 31, 2024K222196Deep TMS System
Brainsway , Ltd., IL
OBP
Aug 26, 2022K220819BrainsWay Deep TMS System
Brainsway , Ltd., IL
OBP
Aug 17, 2021K210201Deep Transcranial Magnetic Stimulation (DTMS) System
Brainsway , Ltd., IL
OBP
Apr 23, 2021K203735Brainsway Deep TMS System
Brainsway , Ltd., IL
OBP
Apr 16, 2021K203616Brainsway Deep (DTMS) System
Brainsway , Ltd., IL
QMD
Aug 21, 2020K200957Brainsway Deep TMS System
Brainsway , Ltd., IL
QMD
Mar 8, 2019K183303Brainsway Deep TMS System
Brainsway , Ltd., IL
QCI
May 3, 2018K173540Brainsway Deep (DTMS) System
Brainsway , Ltd., IL
OBP
Jan 7, 2013K122288BRAINSWAY DEEP TMS SYSTEM
Brainsway , Ltd., IL
OBP

Latest recalls

DateFirm and productCodeLinked 510(k)
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