BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Rotablator™and ROTAPRO™ Rotational Atherectomy System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Reflection Ceramic Hip System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GUIDANT EASY-TRACK 2 LEADS

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Model 400 Implantable Infusion Pump

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·GELSYN-3

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Imagerade MR Conditional Pacing System and Ingevity Pacing/Sense Lead

    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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE® Injectable Implant

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed Infusion System; Ascenda Intrathecal Catheters

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SelectSecure Lead

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS)

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valves

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit and Vitatron Impulse II Lead

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

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery

    Leadless Pacemaker

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