Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HYPERION LTK SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CardioMessenger Smart 4G LTE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DataBridge 4G/LTE Adapter

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Novocure Ltd.'s Optune

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Nevro Corp Senza Spinal Cord Stimulation System

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof ReSTOR Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BioMimics 3D Vascular Stent System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Photopheresis System

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VH8500 HYPERTHERMIA TREATMENT SYSTEM

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t)

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART