2,435 results
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42ms
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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