730 results · 20ms · Sources: EU EUDAMED, US FDA

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 ·cobas BRAF V600 Mutation Test

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 FGFR RGQ RT-PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen KRAS RGQ PCR Kit

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology™

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Surpass Evolve Flow Diverter Systems

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen EGFR RGQ PCR kit

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Surpass Evolve Flow Diverter System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Surpass Streamline Flow Diverter

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Surpass Streamline Flow Diverter

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED) and FRED X System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH1

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device with Shield Technology

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE