65 results · 24ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

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

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM

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 ·FARAWAVE Pulsed Field Ablation Catheter

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

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

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

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,

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 ·FARAPULSE Pulsed Field Ablation 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

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,

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

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)

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

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay