GALILEO GOLD

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS

FDA 510(k)

FDA Class 2 ·General Hospital

THE BIOPSY TOOL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hawkeye Control Unit with Eyas Endoscope

FDA 510(k)

FDA Class 2 ·Orthopedic

SICKLE-CHEX SOLUBILITY KIT

FDA 510(k)

FDA Class 2 ·Hematology

X-CAL

FDA 510(k)

FDA Class 2 ·Hematology

Aspen Laser Systems Therapy Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZOE FLUID STATUS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZapStim Controller Application (Z1023)

FDA 510(k)

FDA Class 2 ·Neurology

OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BEAR and BEAR mini

FDA 510(k)

FDA Class 2 ·Neurology

Cell-Free DNA BCT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QWIK-CALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PlasmaWave

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAL-CHEX CD PLUS

FDA 510(k)

FDA Class 2 ·Hematology

CALIBRATION VERIFICATION ASSESSMENT (CVA)

FDA 510(k)

FDA Class 2 ·Hematology

HERNIAMESH SURGICAL MESHES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SWEDE-VENT IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

MDx-Chex for BCID2

FDA 510(k)

FDA Class 2 ·Microbiology