65 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump)
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Affera Sphere-9 Mapping and Ablation Catheter
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Ablation and Mapping Catheter - AFR-00001
Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
FDA Pre-Market Approval
FDA Class 3
·AvertD and AvertD Buccal Sample Collection Kit
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Catheter and Affera Ablation System
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·VARIPULSE Bi-Directional Catheter
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·PulseSelect PFA Loop Catheter
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Catheter and Affera Ablation System
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Catheter and Affera Ablation System
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump)
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·PulseSelect Pulsed Field Ablation (PFA) system
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable,
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL 101) & (ZL102)
Catheter, Balloon, Urethral, Drug-Coated
FDA Pre-Market Approval
FDA Class 3
·Optilume Urethral Drug Coated Balloon Catheter
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (ZL 102), INTENSIA CRT-D
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi