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

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

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-EBK PLUS Assay

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Wolverine Coronary Cutting Balloon

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

FDA Pre-Market Approval
FDA Class 3 ·ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Renal Monorail Premounted System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NT, NTR, and XTR Clip Delivery System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Model 2740 Programmer

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spnal Cord Stimulation Lea

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra AV TPS, Micra TPS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Sweet TIP® RX Steroid Eluting Lead

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Patient Remote

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim SNS Urinary Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASOSEAL (TM)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB SILSOFT (ELASTOFILCON A) CONTACT LENS

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

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO 3000 CARDIAC ABLATION SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS URINARY EXTENSIONS, SNS URINARY LEADS