Nexstim PLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2320-2017Class IINBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 oMarch 14, 2017
Z-2319-2017Class IINexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation SyMarch 14, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)March 20, 2026
K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)March 20, 2026
K182700Nexstim Navigated Brain Therapy (NBT) System 2March 22, 2019
K171902Nexstim Navigated Brain Therapy (NBT) System 2November 10, 2017
K112881NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)May 22, 2012
K091457NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEMDecember 8, 2009