Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTEC MI-306, MI-327 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

SEKURE Acetaminophen L3K Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LBK 1244 DELFIA HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GOLD GATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECHO GEL (RAINFOREST)

FDA 510(k)

FDA Class 2 ·Radiology

MEGA 5.5 SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

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

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Laser, Ophthalmic

FDA Pre-Market Approval

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