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

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TIER A UV-ABSORBING POSTERIOR CHAMBER INTARA. LENS

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Muscular VSD Occluder

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

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

    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

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Transcatheter Septal Occluder

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANCURE SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD-500 HYPERTHERMIA SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES