42 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIDGE
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
·Dimension FPSA Flex reagent cartridge (RF452)
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic CoreValve Evolut R XL system
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA
Stimulator, Invasive Bone Growth
FDA Pre-Market Approval
FDA Class 3
·EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II
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
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIDGE
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
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIDGE
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
Stimulator, Invasive Bone Growth
FDA Pre-Market Approval
FDA Class 3
·OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech PSA Reagents on the Access Immunoassay Systems
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·Access AFP 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
·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
·Dimension FPSA Flex reagent cartridge
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA ASSAY
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM