Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE/SJM MASTERS SERIES & SJM REGENT HEART VALVES

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 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MECHANICAL HEART VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS & CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTH

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL 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 ·Roche cobas DNA Sample Preparation Kit / Roche cobas 4800 BRAF V600 Mutation Test

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On X Prosthetic Heart Valve Ascending Aortic Prothesis

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas BRAF V600 Mutation Test

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 ·SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT BI-LEAFLET HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC OPEN PIVOT HEART 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 ·AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)