Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·OSTEOBOND(TM) COPOLYMER BONE CEMENT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK (TM)

Control Material, Her-2/Neu, Immunohistochemistry

FDA classification

FDA Class 2 ·Control Material, Her-2/Neu, Immunohistochemistry

System, Test, Her-2/Neu, Monitoring

FDA classification

FDA Class 2 ·System, Test, Her-2/Neu, Monitoring

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)

BioRoot Flow 0.5g, BioRoot Flow 2g

FDA 510(k)

FDA Class 2 ·Dental

Biodentine XP 500, Biodentine XP 200

FDA 510(k)

FDA Class 2 ·Dental

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

FDA classification

FDA Class 2 ·Test, Epithelial Ovarian Tumor Associated Antigen (He4)

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

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

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)