245 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Cancer-Related Germline Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·BRACAnalysis CDx
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
·FoundationOne CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·myChoice CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Guardant360 CDx
Cancer-Related Germline Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·BRACAnalysis CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Cancer-Related Germline Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·BRACANALYSIS CDX
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 CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Guardant360 CDx
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro);RHYTHMIA HDx
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Accent, Assurity, Endurity, Verity ADx, Zephyr, Identity ADx, Victory
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne®Liquid CDx (F1LCDx)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne®CDx (F1CDx)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (F1CDx)
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat CDx FLT3 Mutation Assay
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat CDx FLT3 Mutation Assay
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx, F1CDx