10,000 results · 51ms · Sources: EU EUDAMED, US FDA

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval
FDA Class 3 ·Paradise® Ultrasound Renal Denervation System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY™ XD Everolimus-Eluting Platinum Chromium Co

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·M6-C Artificial Cervical Disc

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS C1512 COCHLEAR IMPLANT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·STAARVISC II,SHELLGEL AND COEASE

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY SYSTEM SNS BOWEL LEADS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INGEVITY LEADS

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

FDA Pre-Market Approval
FDA Class 3 ·Anchoring Sleeve Kit and SelectSecure Lead

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

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

FDA Pre-Market Approval
FDA Class 3 ·Tendril SDX Lead, Tendril ST Lead, OptiSence, Tendril STS Lead

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

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