MILLENNIUM GOLD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SKYTRON MODEL 610-2

FDA 510(k)

FDA Class 2 ·Physical Medicine

SKYTRON UNIVERSE SERIES SURGICAL LIGHTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SKYTRON LIFE ISLAND 21

FDA 510(k)

FDA Class 2 ·General Hospital

SKYTRON INFINITY SERIES SURGICAL LIGHTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SKYTRON ELITE SURGICAL TABLES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AURORA LED SERIES SURGICAL LIGHTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STELLAR SERIES SURGICAL LIGHTS WITH HERMES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STELLAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.

ORTHOMED ORTHOPAEDIC FIXATION STAPLES

FDA 510(k)

FDA Class 2 ·Orthopedic

MTG - MINITUB HEATED STAGE SYSTEMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TUBING CONNECTORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOPAEDIC STAPLES

FDA 510(k)

FDA Class 2 ·Orthopedic

MINITUB MULTI-PURPOSE CASSETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TES-TAPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RS BIOTECH GALAXY 'R' CO2 INCUBATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW