Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·4 OZ. STERILE UNPRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE SALINE PRESERVED SOLUTION

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SORBIC ACID PRESERVED SALINE SOL.PH CHANGE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

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