Brainsway L T D

FDA Filings

This page includes the latest FDA filings for Brainsway L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010300912
FEI Number3010300912
NameBRAINSWAY LTD.
Owner & OperatorBrainsway Ltd.
Contact Address19 Hartom Str. Har Hahotzvim
Jerusalem IL-JM Yerushalayim 91451 IL
US Agent
Importing Logistics Registration
ImporterBrainsway USA Inc.
AddressTwo Bala Plaza, Suite 300
Bala, PA 19004 UNITED STATES
Phone1 844 3867001
FAX1 844 3867002
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address19 Hartom Str. Har Hahotzvim
Jerusalem Yerushalayim, 91451 IL
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
BrainsWay Ltd.
BrainsWay Deep TMS System2022-08-26
Brainsway Ltd.
Brainsway Deep TMS System2021-04-23
Brainsway Ltd.
Brainsway Deep (DTMS) System2021-04-16
Brainsway Ltd.
Brainsway Deep TMS System2020-08-21
Brainsway Ltd.
Brainsway Deep TMS System2019-03-08
Brainsway Ltd.
Brainsway Deep (DTMS) System2018-05-03
BRAINSWAY LTD
Power Supply Module - 115V 2018-03-29
BRAINSWAY LTD
Cart Module 2018-03-29
BRAINSWAY LTD
Cooling System - 24V 2018-03-29
BRAINSWAY LTD
Positioning Module 102B 2018-03-29
BRAINSWAY LTD
H1-Coil 2018-03-29
BRAINSWAY LTD.
Brainsway Deep TMS System2013-06-24
BRAINSWAY, LTD
BRAINSWAY DEEP TMS SYSTEM2013-01-07

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091050720Valencia,Spain -> Long Beach, California14 SKIDS OF DEEP TMS BASE SYSTEM (MEDICAL DEV ICE) IN VOICE NO : T2017 CUSTOM S CLEARANC E BY CORNELL DE LIVERY TO FINAL DESTINATIO N BY CARRIER SHIP TO: PRE FERRED DEPOT 14331 CHAMBER S RD TUSTIN, CA 92780 UNIT ED STATES ATTN: SETH ANDER SON TEL.: 8447702727 H.S.# 9 0189000414 PKG
2018042135761Haifa,Israel -> New York/Newark Area, Newark, New Jersey4 CASES OFEXHIBITION GOODS4 PKG

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