10,000 results · 44ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ENDURANT II STENT GRAFT SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System with STEEN Solution Perfusate

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

FDA Pre-Market Approval
FDA Class 3 ·RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, MOMENTUM™ X4, VIGILIANT™, VIGILIANT™ X4

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SBL-3 Multifocal Intraocular Lens

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata HV Leads

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

FDA Pre-Market Approval
FDA Class 3 ·Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Amulet LAA Occluder

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE

Neuromodulator For Obesity

FDA Pre-Market Approval
FDA Class 3 ·Maestro Rechargeable System

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Zephyr Valve Registry (ZEVR)

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval
FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Puregraft Serene Breast Implant

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure™ Preloaded IOL System / Model B1PC (Clear

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT