Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD SYSTEM

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGOIRITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE