Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE(R) 1000A IP LVAD

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER MODEL C

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A