737 results · 19ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Telemetry Wand

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Reactiv8 Implantable Neurostimulation System

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD Totalys MultiProcessor

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Intellis Spinal Cord Stimulation Systems

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Dissection Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Dissection Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Dissection Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH TX2 TAA ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH TX2 THORACIC ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH TX2 TAA ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith® Dissection Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Dissection Endovascular System