Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT HEART VALVE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas 4800 BRAF V600 Mutation Test

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 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID-BRAF kit

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Ascending Aortic Prosthesis

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)

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 ·cobas BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

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 ·MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas BRAF V600 Mutation Test

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +

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 ·CARBOMEDICS PROSTHETIC HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES