18 results
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28ms
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Sources: EU EUDAMED, US FDA
Nexstim Plc
Manufacturer
🇫🇮 Finland·Eurofins Electric & Electronics Finland Oy
Nexstim Plc
Manufacturer
🇫🇮 Finland·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy
NEXSTIM PLC
FDA registration
NEXSTIM PLC·6 products·🇫🇮 Finland
NBS 6
Device
EU MDR
·
Eu Md Class 2a
·Nexstim Plc·On the market·32 countries
NexSpeech
Device
EU MDD
·
Eu Md Class 2a
·Nexstim Plc·On the market·32 countries
Nexstim Navigated Brain Therapy System
Device
EU MDD
·
Eu Md Class 2a
·Nexstim Plc·On the market·32 countries
Nexstim Navigated Brain Stimulation System
Device
EU MDD
·
Eu Md Class 2a
·Nexstim Plc·On the market·32 countries
NEXSTIM NAVIGATED BRAIN STIMULATION SYSTEM
FDA Adverse Event
Malfunction
·NEXSTIM PLC·Product code HAW·May 5, 2017
Nexstim NBS System 6
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Nexstim Plc·1 device
NexSpeech
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Nexstim Plc·1 device
Nexstim Navigated Brain Therapy System
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Nexstim Plc·1 device
Nexstim Navigated Brain Stimulation System
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Nexstim Plc·1 device
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. 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. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
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. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
CR-03-1087-817-23
Certificate
MDR QMS·Nexstim Plc·Eurofins Electric & Electronics Finland Oy
EUFI29-21000160-S
Certificate
MDD Annex II (excluding section 4)·Nexstim Plc·Eurofins Electric & Electronics Finland Oy·3 Basic UDI-DIs
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. 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. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Recall
Open, Classified
·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017
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. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Recall
Open, Classified
·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017