Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT NOVATION FFDM SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

308nm Excimer UV-light Skin Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser System GP900A8, Diode Laser System GP900Q8

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Light based hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

FDA 510(k)

FDA Class 2 ·Radiology

Air Compression Leg Massager (Model: LY-670D)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Endo Ultrasonic Activator

FDA 510(k)

FDA Class 2 ·Dental

PADSCAN HD SERIES BLADDER SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

Light Based Hair Removal Device GP592

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CO2 Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) SUPRA-CLENS DAILY PROTEIN REMOVER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·AFP CONTROL PACK

DIAZIR

FDA 510(k)

FDA Class 2 ·Dental

PROTEUS 235 PROTON THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

NEBA SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ERCHONIA ML SCANNER (MLS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WEST NILE VIRUS IGM CAPTURE ELISA

FDA 510(k)

FDA Class 2 ·Microbiology