ETEST TETRACYCLINE

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST FOR AZTREONAM

FDA 510(k)

FDA Class 2 ·Microbiology

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ETEST SUBMISSION FOR AZITHROMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

C0-AXIAL INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDANT AXIUS CORONARY SHUNT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arrow 0.2 Micron Flat Filter, GVS

FDA 510(k)

FDA Class 2 ·Anesthesiology

POPS! one Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM

FDA 510(k)

FDA Class 2 ·Orthopedic

SYSTEM U3 FOR CIPROFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDITEC QL-15 ND:YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Quantra Hemostasis Analyzer, QPlus Cartridge

FDA 510(k)

FDA Class 2 ·Hematology

RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ecoFIX®

FDA 510(k)

FDA Class 2 ·Orthopedic

ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Quantra QPlus System

FDA 510(k)

FDA Class 2 ·Hematology

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK

FDA 510(k)

FDA Class 2 ·Immunology

BINAXNOW G6PD TEST

FDA 510(k)

FDA Class 2 ·Hematology