1,314 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS
Stimulator, Low Electric Field, Tumor Treatment
FDA Pre-Market Approval
FDA Class 3
·OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
Placental Alpha Microglobulin-1 Immunoassay
FDA Pre-Market Approval
FDA Class 3
·PartoSure test
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
Placental Alpha Microglobulin-1 Immunoassay
FDA Pre-Market Approval
FDA Class 3
·PartoSure Test
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIDGE
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Dimension Vista TPSA Flex reagent cartridge
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA TPSA ASSAY
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·TPSA FLEX REAGENT
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIDGE