Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTER HP VALVED GRAFT WITH GELWEAVE VALSALVA

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

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 ·SJM MASTERS HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis devices

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 BRAF v600 Muttaion Test

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS MECHANICAL HEART VALVES

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 ·REGENT MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·STARR EDWARDS SILASTIC BALL 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 ·ON-X PROSTHESTIC 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 ·SJM MECHANICAL HEART VALVE, MASTER SERIES COATED AORTIC VALVED GRAFT

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® EGFR Mutation Test, v2.0

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE