2,435 results · 42ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EGFR Mutation Test, v2.0

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR MUTATION TEST v2

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·Koning Breast CT, KBCT (Model CBCT1000)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 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 ·MODEL AT-103(SIZES 19-31MM) & MT-103(SIZES 19-33MM

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 ·REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BILEAFLET-CENTER OPENING CARDIAC VALVE

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·QIAGEN THERASCREEN KRAS RGQ PCR KIT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·REGENT MECHANICAL HEART VALVE, STANDARD AND MASTERS MECHANICAL HEART VALVE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® BRAF V600 Mutation Test