EMIT CARBAMAZEPINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT IMIPRAMINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OCCLUSION BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)

FDA 510(k)

FDA Class 2 ·Radiology

Universal Endometrial Applicator Set (GM11009840)

FDA 510(k)

FDA Class 2 ·Radiology

CADPLAN HELIOS OPTION 6.0

FDA 510(k)

FDA Class 2 ·Radiology

ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)

FDA 510(k)

FDA Class 2 ·Radiology

GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER

FDA 510(k)

FDA Class 2 ·Radiology

COHERENT EXCELITE CO2 AIR FIBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ON-BOARD IMAGER DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

Surface Applicator Set

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: ARAGON SURGICAL LAPCAP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EXCISOR BIOPTOME, MODEL 01-0004

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMIT AMITRIPTYLINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENDOTINE FOREHEAD TRIPLE DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)

FDA 510(k)

FDA Class 1 ·Orthopedic

ACUITY RADIATION THERAPY SIMULATOR

FDA 510(k)

FDA Class 2 ·Radiology

NEOSOFT UMBILICAL VESSEL CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

OPTICAL GUIDANCE PLATFORM

FDA 510(k)

FDA Class 2 ·Radiology

EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology