524 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ELECSYS FREE PSA CALCHECK
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT Free PSA / Alinity i Free PSA
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Elecsys free PSA Test System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 fPSA
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension FPSA Flex reagent cartridge
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA