BEUDAMED
    800 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extension) with the Captivia Delivery System and Valiant Thoracic Sten

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

    FDA Pre-Market Approval
    FDA Class 3 ·Wolverine Coronary Cutting Balloon (Monorail; Over-theWire)

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·TRIPOLE 16 AND TRIPOLE 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44, LAMITRODE 44C LEADS, LAMITRODE 88 LEAD

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

    FDA Pre-Market Approval
    FDA Class 3 ·WOLVERINE Cutting Balloon Micro-Surgical Dilation Catheter

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REVO MRI IPG

    Glenoid Fossa Prosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

    Joint, Temporomandibular, Implant

    FDA Pre-Market Approval
    FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste

    Implant, Auditory Brainstem

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Carotid WALLSTENT Monorail Endoprosthesis

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

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

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN 3 Ultra Transcatheter Heart Valve

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Aveir™ VR Leadless Pacemaker: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ DR Leadless Pacemaker: Aveir™ Leadle

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ADVISA DR IPG,ADVISA DR MRI IPG