E-PASS

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP Z/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE SS+/IMPULSE II

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON

FDA 510(k)

FDA Class 2 ·Neurology

BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD

FDA 510(k)

FDA Unclassified ·Unknown

NA

FDA UDI

Hangwei GE Medical Systems Co., Ltd.·00840682141932·