560 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·HERCEP TEST
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·DAKO HERCEPTEST
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·HERCEPTEST
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·DAKO HERCEPTEST
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·RX HERCULINK ELITE RENAL STENT SYSTEM
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·PALMAZ BALLOON-EXPANDABLE STENT
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 Vista FPSA Flex reagent cartridge (K6452)
Kit, Assay, Progesterone Receptor
FDA Pre-Market Approval
FDA Class 3
·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
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 AND DIMENSION VISTA FPSA 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
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 (RF451)
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·BioFreedom Drug Coated Coronary Stent System
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
Kit, Assay, Progesterone Receptor
FDA Pre-Market Approval
FDA Class 3
·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
Kit, Assay, Estrogen Receptor
FDA Pre-Market Approval
FDA Class 3
·RIANEN 3H