INVIGRA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POCKET SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

TSolution One w/ACG surgical System

FDA 510(k)

FDA Class 2 ·Neurology

TSolution One Surgical System Model 210

FDA 510(k)

FDA Class 2 ·Neurology

TSolution One w/ACG+ Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

TSolution One Cup1 Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ONE STEP MORPHINE CARD TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MDI QUIK TEST NARCOTICS DRUG SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CR3 Keyless Split Sample Cup Morphine - Methamphetamine

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MRI SYTEMS

FDA 510(k)

FDA Class 2 ·Radiology

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

ClearPath Aligner

FDA 510(k)

FDA Class 2 ·Dental

UTERINE TENACLUM HOOK

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Clear Moves Aligner

FDA 510(k)

FDA Class 2 ·Dental

Ensmile

FDA 510(k)

FDA Class 2 ·Dental

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ClearPath Aligner

FDA 510(k)

FDA Class 2 ·Dental