BEUDAMED
    4,612 results · 24ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MemoryGel Enhance Silicone Breast Implants

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY+

    Implantable Pulse Generator, Pacemaker (Non-Crt)

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

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RHA® Redensity, RHA® Redensity Mepi

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt XT MRI ICD

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Heart Failure Risk Status (HFRS), Triage-HF

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

    FDA Pre-Market Approval
    FDA Class 3 ·OrganOx metra System

    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

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

    Intrasaccular Flow Disruption Device

    FDA Pre-Market Approval
    FDA Class 3 ·Woven EndoBridge Aneurysm Embolization (WEB) System

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·Esteem® Totally Implantable Hearing System

    Sealant, Dural

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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP and CP with SmartAssist

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System