Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip System (NT)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·ClearVisc Ophthalmic Viscosurgical Device (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC & AMVISC PLUS OVD

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator (WCD) System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid)

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS