504 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV Assay
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS
Fluorescence Polarization Immunoassay For Cyclosporine
FDA Pre-Market Approval
FDA Class 2
·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·IMX AND AXSYM PSA
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT IMX AFP ASSAY
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·IMX HAVAB-M
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ABBOTT IMX HAVAB-M LIST 2263
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM AFP
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·IMX HAVAB
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT ANTI-HCV
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
FDA Pre-Market Approval
FDA Class 2
·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.0
Tester, Pacemaker Electrode Function
FDA Pre-Market Approval
FDA Class 2
·KENTROX RV-S/KENTROX SL-S ICD LEADS
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Dimension Vista TPSA Flex reagent cartridge (K6451)
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV Assay
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·MENICON SF-P (TM)
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Dimension TPSA Flex Reagent Cartridge
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SENOGRAPHE DS & 2000D FFDM SYSTEM
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0