52 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Finland
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BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
FDA 510(k)
FDA Class 2
·Dental
SCANORA 3DX
FDA 510(k)
FDA Class 2
·Radiology
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-140
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-130-01-20
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-20-561
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-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
CDX-40
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-40
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-40
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-30-05
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-30-05
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-30-02
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-170
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device
CDX-160
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Abacus Diagnostica Oy·1 device