Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoSure Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BGM014 Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MultiSure GK Link Blood Glucose and Ketone Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAL-1A Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoSure HT Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoSure ADVANCE Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MTM301 Blood Glucose and Ketone Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Quantum Pump Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

M2 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Ventilation Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

M4 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET

FDA 510(k)

FDA Class 2 ·Dental

M3 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wearable Device, Wearable Package

FDA 510(k)

FDA Class 2 ·Cardiovascular