4,936 results
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50ms
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Sources: EU EUDAMED, US FDA
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
FDA Pre-Market Approval
BRACAnalysis 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)
Dimension Vista® PROG Calibrator
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414948768·Progesterone Calibrator, 10 (2A x 1.0 mL; 2B x ...
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat CDx FLT3 Mutation Assay