3,491 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Leadless Cardiac Resynchronization Therapy (Crt)
FDA Pre-Market Approval
FDA Class 3
·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
Intracranial Coil-Assist Stent
FDA Pre-Market Approval
FDA Class 3
·Neuroform Atlas® Stent System
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK LEAD SYSTEM
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 pharmDx
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 pharmDx
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 pharmDx
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·Obalon Balloon System with Navigation and Touch
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·OBALON BALLOON SYSTEM