HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGABLE BRAIN BIOPSY CANNULA SET

FDA 510(k)

FDA Class 2 ·Neurology

VASCUMED EZ Y-CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECLERIS SINUSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

STIMEL-03

FDA 510(k)

FDA Class 2 ·Physical Medicine

RITTER IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SAAD PATIENT MONITOR (SPM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMECO SHEATH INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SONIXGPS

FDA 510(k)

FDA Class 2 ·Anesthesiology

DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System

FDA 510(k)

FDA Class 2 ·Neurology

MDT Navigable Brain Biopsy Cannula

FDA 510(k)

FDA Class 2 ·Neurology

CushionCast Moldable Cushions

FDA 510(k)

FDA Class 2 ·Radiology

Navigated Pedicle Access Kit

FDA 510(k)

FDA Class 2 ·Neurology

EMBRACE

FDA 510(k)

FDA Class 2 ·Radiology

CPR EZY MASK AND PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM