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

Controller, Closed-Loop Blood Glucose

FDA classification

FDA Class 3 ·Controller, Closed-Loop Blood Glucose

Enzyme Immunoassay, Fetal Fibronectin

FDA classification

FDA Class 3 ·Enzyme Immunoassay, Fetal Fibronectin

System, Test, Total Antioxidant Status

FDA classification

FDA Class 3 ·System, Test, Total Antioxidant Status

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

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Instrument, Glucose, Noninvasive Technology

FDA classification

FDA Class 3 ·Instrument, Glucose, Noninvasive Technology