AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534

FDA 510(k)

FDA Class 2 ·Cardiovascular

APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OEC One

FDA 510(k)

FDA Class 2 ·Radiology

uCT ATLAS with uWS-CT-Dual Energy Analysis

FDA 510(k)

FDA Class 2 ·Radiology

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Microcatheter and guide-wire system

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAROTID COIL 5000004901

FDA 510(k)

FDA Class 2 ·Radiology

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Automatic Blood Pressure Monitor Model LD-518 & LD-537

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 51

FDA 510(k)

FDA Class 2 ·Cardiovascular

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PC ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Disposable Medical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513

FDA 510(k)

FDA Class 2 ·Cardiovascular

Light Based Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery