2,440 results · 22ms · Sources: EU EUDAMED, US FDA

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·EMS-SWISS DOLORCLAST

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·EMS SWISS DOLORCLAST

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Safire Bi-Directional Ablation Catheters, Livewire TC Ablation Catheter

System, Hemodynamic, Implantable

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

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

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

FDA Pre-Market Approval
FDA Class 3 ·Quickflex µ, Quartet

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Tendril MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata, Optisure

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

FDA Pre-Market Approval
FDA Class 3 ·OptiSense, Tendril STS, Tendril SDX, Tendril ST

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

FDA Pre-Market Approval
FDA Class 3 ·IsoFlex

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Biocor, Biocor Supra, Epic and Epic Supra Heart Valves

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta and Trifecta GT Heart Valves

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Fortify, Fortify Assura, and Ellipse

Implantable Pulse Generator, Pacemaker (Non-Crt)

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

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

FDA Pre-Market Approval
FDA Class 3 ·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads

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

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor