10,000 results · 48ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·EVIA FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Supera Peripheral Stent System, Supera Pro Interwoven Peripheral Stent System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus ABI541 Auditory Brainstem Implant

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System

Stent, Carotid

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

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant

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 Spinal Cord Stimulation Lea

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

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

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

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

FDA Pre-Market Approval
FDA Class 3 ·ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D

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

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Leadless Pacemaker

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Intraocular Lenses with the AutonoMe Delivery System

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·S.M.A.R.T.® CONTROL® Nitinol Stent System, S.M.A.R.T. RADIANZTM Vascular Stent System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Astron Peripheral Self-Expanding Nitinol Stent System

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

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)