GOLD GATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ECHO GEL (RAINFOREST)

FDA 510(k)

FDA Class 2 ·Radiology

BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG

FDA 510(k)

FDA Class 2 ·Cardiovascular

BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LapBox Tissue Containment Removal System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARK Voriconazole II Assay Test System

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

ARK CARE DIABETES MANAGMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRK CONDYLAR RESURFACING TOTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)

FDA 510(k)

FDA Class 2 ·Dental

BONEGEN - TR

FDA 510(k)

FDA Class 2 ·Dental

TEETH IN AN HOUR - ARK IMPLANT CONCEPT

FDA 510(k)

FDA Class 2 ·Dental

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208

FDA 510(k)

FDA Class 2 ·Cardiovascular

GERATHERM MERCUIRY FREE CLINICAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

NEO DENTA ZIRCONIA

FDA 510(k)

FDA Class 2 ·Dental

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology