Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

DZ-Tabone Intervertebral Body Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

Radio Frequency Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Home use hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

aoni Natural Rubber Latex Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AGE Automatic Wrist Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

RSM 1824C with RConsole1

FDA 510(k)

FDA Class 2 ·Radiology

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EVS 4343, EVS 4343G

FDA 510(k)

FDA Class 2 ·Radiology

CARE SU01A SUCTION ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHTMED TRUSCAN 577

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Ultrasonic Surgical & Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISEN-Goggles with Data Viewer

FDA 510(k)

FDA Class 2 ·Neurology

LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER

FDA 510(k)

FDA Class 2 ·Ophthalmic

EASYSTIM NMS-28

FDA 510(k)

FDA Class 2 ·Physical Medicine

BIOEASY Multi-Drug Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Microwave Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

FDA 510(k)

FDA Class 2 ·Dental