15 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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SurgiMedia HD-X
Device
EU MDR
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Eu Md Class 1
·ISIS - INTELLIGENT SURGICAL INSTRUMENTS & SYSTEMS·On the market
OCTOPUS
Device
EU MDR
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Eu Md Class 1
·Substrate HD·On the market·2 countries
DSUB
Device
EU MDR
·
Eu Md Class 1
·Substrate HD·On the market·2 countries
Volta AF-Xplorer II
Device
EU MDR
·
Eu Md Class 2a
·Substrate HD·On the market·8 countries
Volta AF-Xplorer
Device
EU MDR
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Eu Md Class 2a
·Substrate HD·On the market·6 countries
VX1 Hardware
Device
EU MDR
·
Eu Md Class 1
·Substrate HD·On the market·4 countries
VX1 Application
Device
EU MDD
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Eu Md Class 2a
·Substrate HD·On the market·4 countries
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
FDA Enforcement
Class II
·Terminated·EOS Imaging·January 1, 2014
Volta AF-Xplorer II
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Substrate HD·1 device
OCTOPUS
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Substrate HD·1 device
DSUB
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Substrate HD·1 device
Volta AF-Xplorer
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Substrate HD·1 device
VX1 Hardware
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Substrate HD·1 device
VX1 Application
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Substrate HD·1 device
HD 60144656
Certificate
MDD Annex II (excluding section 4)·Substrate HD·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI