811 results · 33ms · Sources: EU EUDAMED, US FDA

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