10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Finland
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Bonalive® putty MIS 2 cc
Device
EU MDD
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Eu Md Class 3
·Bonalive Ltd·On the market·27 countries
Bonalive® putty MIS 2 cc
Device
EU MDD
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Eu Md Class 3
·Bonalive Ltd·On the market·27 countries
ActivaScrew™ Cannulated
Device
EU MDD
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Eu Md Class 3
·Bioretec Ltd.·On the market·22 countries
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 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
Bonalive® putty MIS 2 cc
Basic UDI-DI
EU MDD
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Eu Md Class 3
·Bonalive Ltd·1 device
Bonalive® putty MIS 2 cc
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Bonalive Ltd·1 device
Plandent Oy
Importer
🇫🇮 Finland·43 Manufacturers