740 results · 22ms · Sources: EU EUDAMED, US FDA

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

Kit, Assay, Estrogen Receptor

FDA classification
FDA Class 3 ·Kit, Assay, Estrogen Receptor

Kit, Chemical Snake-Bite

FDA classification
FDA Class 3 ·Kit, Chemical Snake-Bite

Kit, Balloon Repair, Catheter

FDA classification
FDA Class 3 ·Kit, Balloon Repair, Catheter

Kit, Assay, Progesterone Receptor

FDA classification
FDA Class 3 ·Kit, Assay, Progesterone Receptor

Kit, Sample Collection, Hiv

FDA classification
FDA Class 3 ·Kit, Sample Collection, Hiv

Kit, Dna Detection, Human Papillomavirus

FDA classification
FDA Class 3 ·Kit, Dna Detection, Human Papillomavirus

Kit, Rna Detection, Human Papillomavirus

FDA classification
FDA Class 3 ·Kit, Rna Detection, Human Papillomavirus

Kit, Test, Saliva, Hiv-1&2

FDA classification
FDA Class 3 ·Kit, Test, Saliva, Hiv-1&2

Immunohistochemistry Antibody Assay, C-Kit

FDA classification
FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Kit, Test, In Vitro Periodontal

FDA classification
FDA Class 3 ·Kit, Test, In Vitro Periodontal

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA classification
FDA Class 3 ·Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification
FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit