64 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Finland
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JedX 3972 W FT HL
Device
EU MDR
·
Eu Md Class 1
·JedX Medcare·On the market
JedX 3971 W FT HL
Device
EU MDR
·
Eu Md Class 1
·JedX Medcare·On the market
JedX Medcare FFP2 NR
Device
EU MDR
·
Eu Md Class 1
·JedX Medcare·On the market
JedX 3805 W FT HLPV
Device
EU MDR
·
Eu Md Class 1
·JedX Medcare·On the market
JedX 3614 W FT HLVP
Device
EU MDR
·
Eu Md Class 1
·JedX Medcare·On the market
GenomEra CDX Software
Device
EU IVDR
·
Eu Ivd Class A
·Uniogen Oy·On the market
GenomEra CDX System
Device
EU IVDR
·
Eu Ivd Class A
·Uniogen Oy·On the market
SCANORA 3DX
FDA 510(k)
FDA Class 2
·Radiology
JedX 3972 W FT HL
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·JedX Medcare·1 device
JedX 3971 W FT HL
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·JedX Medcare·1 device
JedX Medcare FFP2 NR
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·JedX Medcare·1 device
JedX 3614 W FT HLVP
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·JedX Medcare·1 device
JedX 3805 W FT HLPV
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·JedX Medcare·1 device
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
FDA Enforcement
Class II
·Ongoing·Palodex Group Oy·August 21, 2024
CDX-100
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-100
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-70
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-70
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-60
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-60
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device