OPERATIVE RECORDING CAMERA

FDA 510(k)

FDA Class 2 ·Physical Medicine

StealthStationTM S8 ENT Software

FDA 510(k)

FDA Class 2 ·Neurology

MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIREFLY Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

AngioSculpt PTA Scoring Baloon Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAMMOTEST ADAPTER DRIVER

FDA 510(k)

FDA Class 2 ·Radiology

TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS

FDA 510(k)

FDA Class 2 ·Radiology

TENSWave

FDA 510(k)

FDA Class 2 ·Neurology

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accure Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

FDA 510(k)

FDA Class 2 ·Cardiovascular

Remi Robotic Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1

FDA 510(k)

FDA Class 2 ·Radiology

XIMATRON/CT OPTION

FDA 510(k)

FDA Class 2 ·Radiology

NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS

FDA 510(k)

FDA Class 2 ·Neurology

NeedleCam HD Visualization System

FDA 510(k)

FDA Class 2 ·Orthopedic

STERITEC GREEN CARD PACK BOWIE-DICK TEST

FDA 510(k)

FDA Class 2 ·General Hospital

PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology