Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

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 PROSTHETIC HEART VALVE (CPHV)

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 ·MONOSTRUT CARDIAC VALVE PROSTHESIS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

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 ·Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft

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 ·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VAVLE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVE

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 ·CRCDx RAS Mutation Detection Assay Kit

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT

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 ·THxID BRAF assay kit

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 EGFR MUTATION TEST

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Heart Valve / Aortic Valved Graft