MAR COR SERVICES BICARB SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

G.E.M. WATER SYSTEMS, INTERNATIONAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIPRO MODEL SDS-CB200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIGORA

FDA 510(k)

FDA Class 2 ·Radiology

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INION CPS BSSO SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANEX BASEX D OR CRANEX EXCEL D

FDA 510(k)

FDA Class 2 ·Dental

PLLA PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

FDA 510(k)

FDA Class 2 ·Orthopedic

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology