125 results · 8ms · Sources: EU EUDAMED, US FDA

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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