ANYRAY PORTABLE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VIVAWAVE MICROWAVE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMT Platinum Depthalon Depth Electrode

FDA 510(k)

FDA Class 2 ·Neurology

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);

FDA 510(k)

FDA Class 2 ·Radiology

SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC

FDA 510(k)

FDA Class 2 ·Radiology

Green X 18(Model : PHT-75CHS)

FDA 510(k)

FDA Class 2 ·Radiology

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Triton™ Sacroiliac Joint Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Zenius™, lliad™ and Kora™ Spinal Fixation Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

ACCESS RED BLOOD CELL FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAPIDFIRE SELF DRILLING SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

LIGHTSOURCE OR ILLUMINATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AccelFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Neurophet AQUA (V3.1)

FDA 510(k)

FDA Class 2 ·Radiology

LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDICAL IMAGE PROCESSING UNIT

FDA 510(k)

FDA Class 2 ·Dental

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

FDA 510(k)

FDA Class 2 ·General Hospital