BEUDAMED
    3,100 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·OBALON BALLOON SYSTEM

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ARTEFILL® - PMMA COLLAGEN DERMAL FILLER

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS FREE PSA IMMUNOASSAY

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·ReSure Sealant

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·INSIGHTEC EXABLATE SYSTEM

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Coaptite Injectable Implant

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

    FDA Pre-Market Approval
    FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·FRONTIER/FRONTIER II CRT-P¿S AND AESCULA LEADS

    Lens, Multifocal Intraocular

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

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM THERAPY FOR BOWEL CONTROL

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·ORBERA Intragastric Balloon

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE Xpedition, XIENCE Xpedition SV, XIENCE Xpedition LL Everolimus Eluting Coronary Stent Systems