9 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: France
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EXACTECH GPS
FDA 510(k)
FDA Class 2
·Neurology
EXACTECH GPS
FDA 510(k)
FDA Class 2
·Neurology
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
FDA Enforcement
Class II
·Terminated·Blue Ortho·February 19, 2020
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Cursus3
Device
EU MDR
·
Eu Md Class 1
·GPI France·On the market
Hematos IIG
Device
EU MDR
·
Eu Md Class 1
·GPI France·On the market·3 countries
Cursus3
Basic UDI-DI
EU MDR
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Eu Md Class 1
·GPI France·1 device
Hematos IIG
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·GPI France·1 device
VYGON
Importer
🇫🇷 France·26 Manufacturers