HEMODIALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

LERADO, POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

PENTAX FLEXIBLE DRIODENOFIBERSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AVVIGO'+ Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUINTON STATUS 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

TEGRESS IMPLANT NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology