947 results · 17ms · Sources: EU EUDAMED, US FDA

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Lotus Edge Valve System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·FRED X System

Prosthesis, Posterior Spinal Elements

FDA Pre-Market Approval
FDA Class 3 ·TOPS™ System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE LP CERVICAL DISC

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire® Upper Airway Stimulation System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 780G System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·TRYTON Side Branch Stent

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare HVAD System

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·EVO/EVO+ VISIAN® Implantable Collamer® Lenses

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS™ HF System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·RelayPro Thoracic Stent-Graft System

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·TheraSphere™

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·REVISION OPTICS RAINDROP NEAR VISION INLAY

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Microny family of Pacemakers