Data / Medical devices / Finland / Nexstim Plc

Nexstim Plc: FDA-registered device maker in Helsinki Uusimaa, Finland, 6 510(k) clearances

Name: Nexstim Plc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nexstim Plc is registered with the FDA (registration 3007147067) in Helsinki Uusimaa, Finland. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 20, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007147067
Address: Elimaenkatu 9B, Helsinki Uusimaa, Finland, 00510
Owner or operator: Nexstim Plc (10031252)
Roles: Manufacturer
First device listed: January 7, 2010
Registered through: 2026
Brand names listed: NBS 5+, NBS 6, Navigated Brain Stimulation (NBS), NexSpeech, Nexstim, Nexstim NBS System, Nexstim NBS System 4, Nexstim NBS System 5 and more

Devices it lists

Device	Product code	Class	Role	Source
Electromechanical Arm For A Transcranial Magnetic Stimulation System	QFF	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	QCI	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulator	OBP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 20, 2026	K253098	Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)	OBP	Substantially Equivalent	Nexstim Oyj	accessdata.fda.gov
March 20, 2026	K252358	Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)	OBP	Substantially Equivalent	Nexstim Oyj	accessdata.fda.gov
March 22, 2019	K182700	Nexstim Navigated Brain Therapy (NBT) System 2	OBP	Substantially Equivalent	Nexstim Plc	accessdata.fda.gov
November 10, 2017	K171902	Nexstim Navigated Brain Therapy (NBT) System 2	OBP	Substantially Equivalent	Nexstim Plc	accessdata.fda.gov
May 22, 2012	K112881	NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)	GWF	Substantially Equivalent	Nexstim OY	accessdata.fda.gov
December 8, 2009	K091457	NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM	GWF	Substantially Equivalent	Nexstim OY	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 14, 2017	77198	Class II	Ongoing	Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. Th	Software defect: the NBS software may accidentally generate duplicate copies of one or several files.	accessdata.fda.gov

Compare with other makers

Updated March 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.