IQK-200

FDA 510(k)

FDA Class 2 ·Anesthesiology

UC QIK PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UC QIK 1-STEP HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST

FDA 510(k)

FDA Class 2 ·Immunology

Home Uterine Activity Monitor

FDA Pre-Market Approval

FDA Class 2 ·CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM

Home Uterine Activity Monitor

FDA Pre-Market Approval

FDA Class 2 ·SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVVIGO'+ Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUINTON STATUS 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cordiana Dx16

FDA 510(k)

FDA Class 2 ·Cardiovascular

HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

PREDICTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitalRhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

TM eCloud ECG Analysis System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUALTHERM(R) CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSTATION-100 (CS-100)

FDA 510(k)

FDA Class 2 ·Cardiovascular