Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASULAR AAA SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE CS/SVC LEAD

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR FAMILY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR/DR, RHAPSODY SR/DR, REPLY SR/DR, AND ESPRIT SR/DR PACEMAKERS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY,INTEGRITY,VERITY,VICTORY & ZEPHYR PACEMAKERS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest® Wearable Defibrillator

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SUPARTZ FX and VISCO-3

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity families of ICD Devices

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

FDA Pre-Market Approval

FDA Class 3 ·EASYTRACK 2 Lead, ACUITY Spiral Lead