Clear Aligners

FDA 510(k)

FDA Class 2 ·Dental

Sterilization Wraps

FDA 510(k)

FDA Class 2 ·General Hospital

Wearable Breast Pump (Model S10)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01

FDA 510(k)

FDA Class 2 ·Radiology

BLOOD PRESSURE MONITOR/ MODELS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Implant Planning Software

FDA 510(k)

FDA Class 2 ·Radiology

Heel Incision Safety Lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Radio Frequency Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digital Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

GAUNYING INFRARED LAMP

FDA 510(k)

FDA Class 2 ·Physical Medicine

Med-link Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Disposable Automatically Retractable Insulin Safety Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

FDA 510(k)

FDA Class 2 ·Neurology

TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370

FDA 510(k)

FDA Class 2 ·General Hospital