System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MemoryGel/MemoryGel Xtra Breast Implants

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CRYOABLATION SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MemoryShape Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Silicone Filled Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Saline-Filled and Spectrum Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Saline Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Cool Point Tubing Set

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX SD, TD & S/T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST/JT, SETROX S & DEXTRUS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Tryton Side Branch Stent

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·HULKA CLIP FOR TUBAL OCCLUSION

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity, RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi