Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14 day Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MMT-7002 & MMT-7003 GLUCOSE SENSORS

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING 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 ·iPro2 Continuous Glucose Monitoring (CGM) System with Enlite Sensor

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

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Implanted, Non-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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time System and Paradigm Real-Time Revel System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14 day Flash Glucose Monitoring System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System