Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim System

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Puregraft Serene Breast Implant

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·SMART-MSP

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOneCDx (F1CDx)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST OPTIM AND RIATA STS OPTIM LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CRYOCONSOLE SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus QP Pacing Leads

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM)

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL EXACT SPINE SEALANT

Scaffold, Dissection Repair

FDA Pre-Market Approval

FDA Class 3 ·Tack Endovascular System (6F)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CORONARY DILATATION CATHETERS

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

MELODY TRANSCATHETER PULMONARY VALVE , ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure System/Prostar XL Percutaneous Vascular Surgical System

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SILICOM(TM) 1000 RETINALTAMPONADE

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL

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

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE