BEUDAMED
    1,633 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

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

    FDA Pre-Market Approval
    FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate II LVAS

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·INTERCEED ABSORBABLE ADHESION BARRIER

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

    FDA Pre-Market Approval
    FDA Class 3 ·R3™ Delta Ceramic Acetabular System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·prodisc® C

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·prodisc® L

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·TRIFECTA VALVE

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL Cochlear Implant System

    Bone Grafting Material, Dental, With Biologic Component

    FDA Pre-Market Approval
    FDA Class 3 ·GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·BIOCOR/EPIC VALVE

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Kysse

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·CERVISTA HPV HR

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·CERVISTA HPV 16/18