730 results · 19ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

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

Intracranial Aneurysm Flow Diverter

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas KRAS Mutation Test

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 ·Roche cobas KRAS Mutation Test

Intracranial Aneurysm Flow Diverter

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

Intracranial Aneurysm Flow Diverter

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

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 4800 BRAF V600 MUTATION TEST

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec

Intracranial Aneurysm Flow Diverter

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

Intracranial Aneurysm Flow Diverter

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

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

Intracranial Aneurysm Flow Diverter

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

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