18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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GEM OPTICS SARL
FDA registration
GEM OPTICS SARL·2 products·🇫🇷 France
37978
Certificate
MDD Annex II (excluding section 4)·NEHS DIGITAL·GMED SAS·1 Basic UDI-DI
35939
Certificate
MDD Annex II (excluding section 4)·NEHS DIGITAL·GMED SAS·1 Basic UDI-DI
35938
Certificate
MDD Annex II (excluding section 4)·NEHS DIGITAL·GMED SAS·1 Basic UDI-DI
OKO SOLUTION
Importer
🇫🇷 France·11 Manufacturers
GE Medical Systems SCS
Authorized representative
🇫🇷 France·27 Manufacturers·564 Devices
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Senographe Pristina
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·February 14, 2024
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·October 15, 2025