31 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Gonococcal Antibody Tests
FDA Pre-Market Approval
FDA Class 3
·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·Rapid fFN for the TLiIQ System
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A)
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Cerene Cryotherapy Device (Model Number FGS-7000)
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·TLiIQ QCette
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Cerene Cryotherapy Device
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THXID-BRAF KIT
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Analyzer, Data, Obstetric
FDA Pre-Market Approval
FDA Class 3
·STAN S31 FETAL HEART MONITOR
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·ADEZA FETAL FIBRONECTIN EIK