10,000 results · 54ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Myocardial Pacing Lead

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

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

FDA Pre-Market Approval
FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VITALITY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Advisa SR MRI, Relia IPG

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY ENERGY ASPHERE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Simplify Disc

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm® Volux™ XC

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS Endoprosthesis

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Angio Seal Vascular Closure Device