571 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AFP (LN 3P36)
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AXSYM AFP
Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
FDA Pre-Market Approval
FDA Class 3
·AvertD and AvertD Buccal Sample Collection Kit
Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
FDA Pre-Market Approval
FDA Class 3
·AvertD and AvertD Buccal Sample Collection Kit
Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
FDA Pre-Market Approval
FDA Class 3
·AvertD and AvertD Buccal Sample Collection Kit
S80 IMPLANTABLE CARDIAC PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Nucleus 24 Cochlear Implant System