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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ATS MEDICAL OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

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 ·CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·On-X Prosthetic Heart Valve, Model Onxa

Heart-Valve, Mechanical

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

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