Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL INSULIN PUMP

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMP

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System Pump

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 ·SEN-SERTER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CARELINK PERSONAL SOFTWARE

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System With SmartGuard

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

WHITESIDE ACRYLIC CEMENT SPACER SLEEVE

FDA 510(k)

FDA Class 3 ·Unknown

Kit, Assay, Estrogen Receptor

FDA classification

FDA Class 3 ·Kit, Assay, Estrogen Receptor

Automated Insulin Dosing , Threshold Suspend

FDA classification

FDA Class 3 ·Automated Insulin Dosing , Threshold Suspend

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA classification

FDA Class 3 ·Continuous Glucose Monitor, Implanted, Adjunctive Use

Sensor, Glucose, Invasive

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA classification

FDA Class 3 ·Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

Hyaline Membrane Disease Assay

FDA classification

FDA Class 3 ·Hyaline Membrane Disease Assay

Sensor, Glucose, Invasive, Non-Adjunctive

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive

Automated Insulin Dosing Device System, Bihormonal Control

FDA classification

FDA Class 3 ·Automated Insulin Dosing Device System, Bihormonal Control