69 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DiaSorin ETI-EBK PLUS assay
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Axium Neurostimulator System
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·BRIO NEUROSTIMULATION SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·EMS-SWISS DOLORCLAST
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·EMS SWISS DOLORCLAST
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery