649 results · 18ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·DUROMEDICS BILEAFLET HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Open Pivot Heart Valves and Open Pivot Aortic Valved Graft

Somatic Gene Mutation Detection System

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

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 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

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 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

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 ·Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)

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 ·ON-X PROSTHETIC HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (22MM)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·QIAGEN THERASCREEN EGFR RGQ PCR 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 ·CARBOMEDICS PROSTHETIC HEART VALVE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas KRAS Mutation Test

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·KONING BREAST CT (MODEL CBCT1000)

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 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT