BEUDAMED
    947 results · 18ms · 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 780G System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RHA® Redensity™ Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi

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

    FDA Pre-Market Approval
    FDA Class 3 ·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE FAMILY OF ICDS

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense®

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

    FDA Pre-Market Approval
    FDA Class 3 ·DiamondTemp Ablation System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Symfony Toric IOL

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

    FDA Pre-Market Approval
    FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·SBL-3 Intraocular Lens

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·remede® System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

    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

    Sealant, Dural

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

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon