Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV Mg/Mn

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval

FDA Class 3 ·POLYTEF PASTE FOR INJECTION

Antigen, Cancer 549

FDA Pre-Market Approval

FDA Class 3 ·TRUQUANT(R) BR(TM) RIA

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·V1. 2A PROGRAMMER SOFTWARE

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·V.1 2A PROGRAMMER SOFTWARE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRILL PASSIVE PLUS/AU PLUS DX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX TUL LEAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL SDX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AV PLUS DX

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·INSPIRE II UPPER AIRWAY STIMULATOR

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

FDA Pre-Market Approval

FDA Class 3 ·TactiFlex™ Ablation CatTactiFlex™ Ablation Catheter, Sensor Enabled™heter, Sensor Enabled™, TactiSys™ Quartz Equipment,

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Livewire™ TC XLS™ Ablation Catheter, Livewire™ TC XLS™ Bi-Directional Ablation Catheter, Livewire™ TC Catheter Extension

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

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

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility™ Ablation Catheter, FlexAbility™ Ablation Catheter, Sensor Enabled™

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DISCOVISC™ Ophthalmic Viscosurgical Device

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System