10,000 results · 40ms · Sources: EU EUDAMED, US FDA

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

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

PIKOS 01 & PIKOS E 01

FDA 510(k)
FDA Class 3 ·Cardiovascular

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE Transcarotid Stent System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Muscular VSD Occluder

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder