5,905 results · 21ms · Sources: EU EUDAMED, US FDA

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G Insulin Pump

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC PARADIGM CONTINUOUS GLUCOSE MONITORING SYSTEMS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·GURADIAN LINK TRANSMITTER

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

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 BICARBONATE BUFFER TEST SYSTEM)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·TLC-II PLUS PORTABLE VAD DRIVER

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Guardian Sensor 3

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Synvisc and Synvisc-One

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MYSENTRY SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME REVEL INSULIN PUMP

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm REAL-Time Revel Insulin Pump

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·iPro2 Continuous Glucose Monitoring (CGM) System with Enlite System