10,000 results · 39ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine samaritan Public Access Automated External Defibrillators and Accessories

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval
FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK(R) CLEAD SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CPI MODEL4262 PACE LEAD ,MODIFY TECH MANUAL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·JEWEL AF, GEM III AT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM AVT AICD SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

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

FDA Pre-Market Approval
FDA Class 3 ·THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)