125 results
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8ms
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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 PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense® Continuous Glucose Monitoring System
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Valved Conduit
Sensor, Glucose, Implanted, Non-Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense® E3 Continuous Glucose Monitoring System
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Mitral Bioprosthesis
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense Continuous Glucose Monitoring System
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve
Sensor, Glucose, Implanted, Non-Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense Continuous Glucose Monitoring System
Sensor, Glucose, Implanted, Non-Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense E3 Continuous Glucose Monitoring System
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33 mm
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC