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

DIGITAL ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Plastic LOR Syringe

FDA 510(k)

FDA Class 2 ·Anesthesiology

HygePLUS Alginate Impression Material

FDA 510(k)

FDA Class 2 ·Dental

IPL hair removal machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Biofeedback Nerve and Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Wearable Breast Pump (Model S1DW)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

uMR 560

FDA 510(k)

FDA Class 2 ·Radiology

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry