213 results · 20ms · Sources: EU EUDAMED, US FDA

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSIAC PORCINE BIOPROSTHESIS, MODELS 305, 310

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock Valved Conduit Low Porosity

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

FDA Pre-Market Approval
FDA Class 3 ·Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir VR

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

FDA Pre-Market Approval
FDA Class 3 ·Avant HF, Avant HF, Gallant HF, Entrant HF, Quadra Assura MP, Quadra Assura, Unify Assura, Quartet, QuickFlex Micro

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·RESTORE, ITREL, SYNERGY

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA, SOLETRA, KINETRA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Endurity MRI, Assurity MRI

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Evolut R and Evolut PRO

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MO VALVED CONDUITS, MODEL 150

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Hancock Valved Conduit Modified Orifice

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Evolut PRO+ Transcatheter Aortic Valves of the Evolut PRO+ System