4,290 results · 20ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Devices: AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 CRT-D Devi

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INGEVITY Distal Tip Laser Weld Process

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer PFO Occluder

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™, A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·COSMOS(TM) SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Acuity Steerable Lead System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL & CONTAK RENEWAL 3 RF

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Accessory Kit

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

FDA Pre-Market Approval
FDA Class 3 ·Thinline Endocardial Pacing Leads

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Accessory Hex Wrench

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II CARDIAC ABLATION CATHETERS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ACUITY STEERABLE FAMILY OF LV PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 CRT-D, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer OI, IntellaNav OI, IntellaTip MiFi OI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Emblem S-ICD System Model A209 / Emblem MRI S-ICD System Model A219