PEAK EXPIRATORY FLOW METER

FDA 510(k)

FDA Class 2 ·Anesthesiology

OMEGASCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PREGNASLIDE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PUNCTURE CLOSURE DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESIGN MI MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

TRANSFX EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEO DYNATROC PROXIMAL FEMORAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

GYREX 2T-DLX

FDA 510(k)

FDA Class 2 ·Radiology

United Orthopedic Knee Patient Specific Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

REJUVENATE MODULAR HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS

FDA 510(k)

FDA Class 2 ·Orthopedic

ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSTEO ANATOMICAL BONE PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNERGY SPINAL SYSTEM (6.35 POLARIS)

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEOLOCK ACETABULAR SHELL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI ACUMEN SURGICAL NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

PACEART TX3 CARDIAC EVENT RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS

FDA 510(k)

FDA Class 2 ·Orthopedic