2,435 results · 39ms · Sources: EU EUDAMED, US FDA

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 KRAS Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·RealTime IDH2

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT

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 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC HALL

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 EGFR MUTATION TEST

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·STARR EDWARDS SILASTIC BALL VALVE, MODELS 1260 AND 6120

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 ·BILEAFLET-CENTER OPENING CARDIAC 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 ·MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Carbomedics Prosthetic Heart Valve

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Open Pivot Aortic Valved Graft (AVG)

Heart-Valve, Mechanical

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

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 ·cobas 4800 BRAF V600 Mutation Test