10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Finland
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NBS 6
Device
EU MDR
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Eu Md Class 2a
·Nexstim Plc·On the market·32 countries
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
FDA 510(k)
FDA Class 2
·Neurology
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)
FDA Class 2
·Neurology
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)
FDA Class 2
·Neurology
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
Nexstim NBS System 6
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Nexstim Plc·1 device
BBS-Bioactive bone substitutes Oyj
Manufacturer
🇫🇮 Finland
NeoMass AAAC Plus dried blood spot (DBS) controls
Device
EU IVDD
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Eu Ivd Annex 2 List B
·Labsystems Diagnostics Oy·On the market
DELFIA/AutoDELFIA PAPP-A/Free hCGβ Dual DBS kit
Device
EU IVDD
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Eu Ivd Annex 2 List B
·Wallac Oy·On the market·32 countries