4,580 results · 21ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·Covera™ Vascular Covered Stent

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Astron Pulsar and Pulsar-18 Stent Systems

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Solesta Injectable Gel

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular MicroBypass System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Hybrid L24 Cochlear Implant System

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE SYSTEM

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·APTIMA HPV ASSAY

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Prestiege LP Cervical Disc - Two-Level

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Attain Ability Model 4196

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MemoryGel, MemoryGel Xtra Silicone Gel-Filled Breast Implants

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Carotid Wallstent Monorail Endoprosthesis

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS

Diagnostic Low Electric Field

FDA Pre-Market Approval
FDA Class 3 ·MarginProbe System

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

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix Novus MRI SureScan Lead