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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·TactiFlex SE Ablation Catheter, Sensor Enabled

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·PSW 2202.U and NEO 2202.U

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE CONSULT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·Renamic Neo Programmer

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·REVEAL DX, REVEAL XT

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·PSW 2201.U/1 and NEO 2201.U/1

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE CONSULT SYSTEM