BEUDAMED
    168 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·RF Marinr, Unipolar Mapping RF Marinr, RF Conductr MC, RF Enhancr, and RF Contactr

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

    Agent, Occluding, Vascular, Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·VenaSeal Closure System

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·SEPRAFILM ADHESION BARRIER

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Proo Delivery Catheter Sys

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic Core ValvE Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic

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

    FDA Pre-Market Approval
    FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™

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

    FDA Pre-Market Approval
    FDA Class 3 ·Anchoring Sleeve Kit and SelectSecure Lead

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Myocardial Pacing Lead

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·DF-1 Connector Port Pin Plug, IS-1 COnnector Port Pin Plug Kit, Springt Quattro Lead, Subcutaneous Lead, and Transvene C

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Transvene CS/SVC Lead

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure SP and Z Novus Lead, Vitatron Excellence SS+ Lead and Vitatron Impulse II Lead

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·End Cap and Upsizing Sleeve