P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1

FDA 510(k)

FDA Class 2 ·Radiology

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAPTIVATE® Compression Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

DuraPro™ Oscillating System

FDA 510(k)

FDA Class 2 ·Neurology

BIOCLONE'S ELEGANCE IGE ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROS-TR SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

BIOCLONE'S ELEGANCE HCG ELISA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

A-V IMPULSE SYSTEM MODEL 6060

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMAGE TRANSPORT SERIES II

FDA 510(k)

FDA Class 2 ·Radiology

CELLABS GIARDIA CEL I.F. TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORBEL Spacers

FDA 510(k)

FDA Class 2 ·Orthopedic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE TM 2501

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500