SYNOVIS COLLAGEN MATRIX (TBD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTFE FELTS AND PLEDGETS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHASE CARDIOVASCULAR PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

NERVE MONITORING CABLE

FDA 510(k)

FDA Class 2 ·Neurology

IVENA VASCULAR PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

DMS Disposable Subdermal Needle Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

VASCU-GUARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMI CARDIOVASCULAR PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

MR CONDITIONAL PRESSON ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON MULTI-PURPOSE SOLUTION ID 81573

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V) BIOPROSTHESIS,MODEL 2650

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS,MODELS 2625 & 6625