Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Lead Models 6935, 6944, 6947

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Sensor (3) System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·BIOCOR, EPIC AND EPIC SUPRA VALVE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN CT TRANSCATHETER HEART VALVE

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE INJECTABLE IMPLANT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG