HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

U.S. IOL PHACO HANDPIECE

FDA 510(k)

FDA Class 2 ·Ophthalmic

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IOB Warming Blankets

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHACO TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

EVOLUTION PHACOMULSIFIER

FDA 510(k)

FDA Class 2 ·Ophthalmic

IOB Temperature Management System

FDA 510(k)

FDA Class 2 ·Cardiovascular

FilteredFlo Warming Blankets

FDA 510(k)

FDA Class 2 ·Cardiovascular

IOB Warming Blankets

FDA 510(k)

FDA Class 2 ·Cardiovascular

IOB Temperature Management System

FDA 510(k)

FDA Class 2 ·Cardiovascular

IOB DISPOSABLE SPECULUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

G Surgical Marksman MIS System

FDA 510(k)

FDA Class 2 ·Orthopedic

CUFF, BLOOD PRESSURE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

SENSOMAT MUSCLE/TISSUE PH

FDA 510(k)

FDA Class 2 ·Anesthesiology