BEUDAMED
    10,000 results · 37ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BioGlue Surgical Adhesive

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

    Implantable Cardioverter Defibrillator (Non-Crt)

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

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Praxis (MiSeqDx) Extended RAS Panel

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra AV TPS, Micra TPS

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·Sphere-9™ Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc

    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 Pro Delivery Catheter Sys

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

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

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ACTIVITRAX MODELS 8400, 8402, 8403

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

    Implantable Pacemaker Pulse-Generator

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

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS Total Knee System

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN ABILITY LEAD

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

    FDA Pre-Market Approval
    FDA Class 3 ·CONSULTA CRT-P,SYNCRA CRT-P