Nexstim PLC
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2319-2017 | Class II | Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation Sy | March 14, 2017 |
| Z-2320-2017 | Class II | NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 o | March 14, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 | March 22, 2019 |
| K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | November 10, 2017 |
| K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) | May 22, 2012 |
| K091457 | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM | December 8, 2009 |