63 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·EDWARDS INTUITY ELITE Valve/Delivery System
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System and Verify Evaluation System (SNS Urinary)
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SynchroMed Infusion System and Ascenda Intrathecal Catheters
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System and Verify Evaluation System (SNS Bowel)
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-LI (SP142) Assay
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-LI (SP263) Assay
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX Reflux Management System
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REGLUX MANAGEMENT SYSTEM
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX Reflux Management System
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·ANGELCHIK ANTI-REFLUX PROSTHESIS
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·ANGELCHIK ANTI-REFLUX PROSTHESIS
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX Reflux Management System
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX Reflux Management System