Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Gambro Prismaflex TPE 2000 Set

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN & SEVEN PLUS SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MiniMed iPro2 CGM System with Enlite Sensor

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·CURESIS PLASMA SEPARATOR

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo™ OP-05W(A)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro™ 2 CGM System with Enlite™ Glucose Sensor

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Sensor 3

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 CGM System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time Revel System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEV-0016 CARELINK PERSONAL SOFTWARE VERSION 1.0A

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Enlite Sensor (MMT-7008)