557 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT Total PSA and Alinity i Total PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT Free PSA and Alinity i Free PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMUNOASAY, PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Advia Centaur PSA Immunoassay and Atellica IM PSA Immunoassay
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY AND ELECYS TOTAL PSA CALSET
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR PSA & ADVIA CENTAUR CP PSA IMMUNOASSAY
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·XIENCE V/nano Everolimus Eluting Coronary Stent System
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 FREE PSA AND IMMULITE 2000 FREE PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·VIDAS TOTAL PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ELECSYS FREE PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech PSA