10,000 results · 47ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Gore Excluder AAA Endoprosthesis

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·EPIC SELF-EXPANDING NITINOL STENT SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir VR and DR Delivery Catheters

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

FDA Pre-Market Approval
FDA Class 3 ·DYNAGEN ™ CRT-D: G150, G151, G154 DYNAGEN ™ X4 CRT-D: G156, G158; INOGEN ™ CRT-D: G140, G141 INOGEN ™ X4 CRT-D: G146, G1

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx Downstream System

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ELCA Laser Catheters

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·REPLY & ESPRIT SR/DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD AND MAXIMO VR ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PROXIMAL (D01) CONNECTOR

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

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA/VERSA/SENSIA

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·ZOLL AED Plus and ZOLL Fully Automatic AED Plus

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Tendril MRI Lead

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure Sense Lead, Vitatron Crystalline Lead

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ Vascular Stent System