210 results · 26ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed™ 530G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed™ 630G System with SmartGuard™

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm™ Real-Time Revel™ System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed™ 670G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian™ Connect system

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Dexcom G5 Platinum Contiuous Glucose Monitoring System

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash 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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·CARELINK IPRO THERAPY MANAGEMENT SOFTWARE

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 530G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System with Enlite Sensor

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Paradigm Real-Time Revel System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232