15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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ABX PENTRA URINE CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
sthemO VWF cal
Device
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·On the market·27 countries
sthemO Heparin cal
Device
EU IVDR
·
Eu Ivd Class C
·Diagnostica Stago·On the market·27 countries
sthemO FDP cal
Device
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·On the market·27 countries
ABX PENTRA TPU CAL, MODEL A11A01898
FDA 510(k)
FDA Class 2
·Clinical Chemistry
sthemO Heparin cal
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Diagnostica Stago·1 device
sthemO FDP cal
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
sthemO VWF cal
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
Pin for ACL reconstruction
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·S.B.M. SAS·24 devices
Stopper for ACL reconstruction
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·S.B.M. SAS·2 devices
Bone tap for ACL reconstruction
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·S.B.M. SAS·5 devices
Chondral pick for ACL reconstruction
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·S.B.M. SAS·1 device
Aiming device for ACL reconstruction
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·S.B.M. SAS·2 devices
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023