NERVUS MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

TRANSPARENT ANESTHESIA FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BREATHING FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

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

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12

FDA 510(k)

FDA Class 2 ·Hematology

CO2 REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICRO CO2 APPARATUS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PowerFlow Apheresis I.V. Port

FDA 510(k)

FDA Class 2 ·General Hospital

OrthoSolutions 'System26' Bone Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Ortho Solutions Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

COGNiTiON™ Staple System

FDA 510(k)

FDA Class 2 ·Orthopedic