811 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·MI Cancer Seek
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH2
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen FGFR RGQ RT-PCR Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen PIK3CA RGQ PCR Kit
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne®Liquid CDx
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·RealTime IDH2
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen PDGFRA RGQ PCR Kit
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·RESOLUTION ctDx FIRST
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)
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·GENESIS NEUROSTIMULATION (IPG) SYSTEM
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·COFLEX® INTERLAMINAR TECHNOLOGY
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·GENESIS NEUROSTIMULATION (IPG) SYSTEM
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·VIBRANT SOUNDBRIDGE SYSTEM
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·VIBRANT SOUNDBRIDGE SYSTEM
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·VIBRANT SOUNDBRIDGE EAR IMPLANT SYSTEM
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·VIBRANT SOUNDBRIDGE SYSTEM