BEUDAMED
    4,612 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA™ Implant System

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFPORT/SOFLEX INTRAOCULAR LENSES

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RHA 3

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR)

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular,

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

    FDA Pre-Market Approval
    FDA Class 3 ·VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; nGEN (TM) Pump

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

    FDA Pre-Market Approval
    FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

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

    FDA Pre-Market Approval
    FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Aurora EV-ICD System

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

    FDA Pre-Market Approval
    FDA Class 3 ·PulseSelect™ Pulsed Field Ablation (PFA) system

    Tissue Adhesive Internal Use

    FDA Pre-Market Approval
    FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·WRAPSODY Cell-Impermeable Endoprosthesis

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

    FDA Pre-Market Approval
    FDA Class 3 ·FARAPULSE Pulsed Field Ablation System

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·AGENT Paclitaxel-Coated Balloon Catheter

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·CraniSeal Dural Sealant

    Pulmonary Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

    Tricuspid Valve Repair Device, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·TriClip™ G4 System