Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX PSA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECHT AFP

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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

DESKREM-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BrainScope One

FDA 510(k)

FDA Class 2 ·Neurology

FONIX, MODEL 7000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FONIX ,MODEL 8000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EyeBOX

FDA 510(k)

FDA Class 2 ·Neurology

Nurochek-Pro System

FDA 510(k)

FDA Class 2 ·Neurology

INSERTION GAIN OPTIMIZER IGO-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Nurochek-II System

FDA 510(k)

FDA Class 2 ·Neurology

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

syngo.CT Lung CAD (Version VD30)

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 340 PROBE MIC SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Jabra Enhance Plus

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat