190 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AXSYM AFP
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
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FREESTYLE NAVIGATOR
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·DERMAGRAFT-TC(TM)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA Pre-Market Approval
FDA Class 3
·MED-EL COCHLEAR IMPLANT SYSTEM