Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Toric1-Piece Intraocular Lenses (IOLs) Models ZCT300 and ZCT400

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·ReVision Optics Raindrop Near Vision Inlay

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·ARTISAN/VERISYSE PHAKIC IOL

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE DEVICES & PROMOTE ACCEL DEVICES

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·VISIONCARE IMPLANTABLE MINIATURE TELESCOPE

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Integrated Dual Ballon System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS Systems)