Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK (TM)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND TOPICAL SKIN ADHESIVE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ONGUARD

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 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·HIGH VISCOSITY DERMABOND MINI APPLICATOR

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

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 ·ICAD SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)

Bone Grafting Material, For Dental Bone Repair

FDA Pre-Market Approval

FDA Class 2 ·CERASORB DENTAL