649 results · 26ms · Sources: EU EUDAMED, US FDA

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 ·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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ATS OPEN PIVOT HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)

Somatic Gene Mutation Detection System

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS Prosthetic Heart Valve (CPHV)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MASTERS SERIES VALVE: PTFE SEWING CUFF

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·EPIC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve – AP360

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE