BEUDAMED
    395 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stent, Coronary

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

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·Plasmaflo OP-05W(A)

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System™ (OCS™) Heart

    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System™ (OCS™) Lung

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System™ (OCS™) Liver

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare® HVAD System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·LUMAX FAMILY OF ICDS AND CRT-DS

    HEARTSINE SAMARITAN PAD 350P

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·H.E.L.P. PLASMAT FUTURA SYSTEM

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Gore Cardioform ASD Occluder

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE CARDIOFORM SEPTAL OCCLUDER

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·ADEPT Adhesion Reduction Solution

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·nGEN™ Pump

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER LA-15 System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·SCULPTRA AND SCULPTRA AESTHETIC

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO