388 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Immunohistochemistry Assay, Antibody, Folr1
FDA Pre-Market Approval
FDA Class 3
·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
FDA Pre-Market Approval
FDA Class 3
·MicroTransponder® Vivistim® Paired VNS System (Vivistim® System)
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1 Assay
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
FDA Pre-Market Approval
FDA Class 3
·Vivistim® System
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
FDA Pre-Market Approval
FDA Class 3
·ADCON-L ADHESION CONTROL IN A BARRIER GEL
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·MI Cancer Seek
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH2
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen FGFR RGQ RT-PCR Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen FGFR RGQ RT-PCR Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
FDA Pre-Market Approval
FDA Class 3
·ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL
Stimulator, Functional Neuromuscular, Scoliosis
FDA Pre-Market Approval
FDA Class 3
·SCOLITRON(TM) STIMULATOR
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Stimulator, Functional Neuromuscular, Scoliosis
FDA Pre-Market Approval
FDA Class 3
·SCOLITRON(TM) STIMULATOR
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·MI Cancer Seek
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH2
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1