Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES, CEEON MODELS 911A & 913A, TECNIS MODELS Z9000

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER AND CELSIUS® THERMOCOOL® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMP

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE LVAS SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT TAA STENT GRAFT DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Thoracic Stent Graft System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas 4800 BRAF V600 Mutation Test

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor® Saline-Filled and SPECTRUM® Breast Implants

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Pleural Air Leak Sealant

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled Ablation Catheter

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE VE LVAS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Hancock Modified Orifice Valved Conduit

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION