BEUDAMED
    10,000 results · 61ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CYLOS/PROTOS/AXIOS/PHILOS II & PHILOS/PHILOS DR-T PULSE GENERATORS

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

    FDA Pre-Market Approval
    FDA Class 3 ·Open-Irrigated Ablation Catheters: Blazer OI, IntellaTip MiFi OI, and IntellaNav OI

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·DIAMONDBACK 360® and Diamondback 360 Precision™ Coronary Orbital Atherectomy System (OAS)

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM WITH THE XCELERANT AND CAPTIVA DELIVERY SYSTEM

    Telescope, Implantable, Miniature

    FDA Pre-Market Approval
    FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI, Endurity MRI, Zenus MRI and Zenex MRI Family of Pacemakers

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)

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

    FDA Pre-Market Approval
    FDA Class 3 ·Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)