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

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Praxis Extended RAS Panel

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·AUTOPAP SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·PREPSTAIN SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·PREPSTAIN SYSTEM

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification
FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD FOCALPOINT GS IMAGING SYSTEM

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification
FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·COBAS HPV TEST

Processor, Cervical Cytology Slide, Automated

FDA classification
FDA Class 3 ·Processor, Cervical Cytology Slide, Automated

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·APTIMA HPV ASSAY