207 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THxID-BRAF assay kit
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·VIDAS TOTAL PSA (TPSA)
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THxID-BRAF kit
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LASERVISION/VISX EXCIMER LASER MODEL C
Organ Care System (Ocs) Heart System
FDA classification
FDA Class 3
·Organ Care System (Ocs) Heart System