Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MemoryGel Enhance Silicone Breast Implants

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY+

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

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

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS LEAD MODEL 5594

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM II, MODEL 3058 NEUROSTIMULATOR

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MemoryGel Breast Implants

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT MRI ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Heart Failure Risk Status (HFRS), Triage-HF

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22(TM) TEST

Contrast Media, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM