BEUDAMED
    79 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Amulet™ Left Atrial Appendage Occluder

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·FlexNav™ and Navitor Loading System, FlexNav™ Delivery System

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform”

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Restore, Itrel®, Synergy®, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectr

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00

    Device, Hemostasis, Vascular

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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·WaveWriter Alpha, WaveWriter Alpha 16

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Genus R32, Vercise Genus R16

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEXGEN COMPLETE KNEE SOLUTION

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Alternative Active Anchor (part number 104504)

    Sealant, Dural

    FDA classification
    FDA Class 3 ·Sealant, Dural

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR