BEUDAMED
    1,107 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS

    Pulmonary Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Vistakon (Senofilcon A) Brand Contact Lenses

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Exoseal Vascular Closure Device

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·The 4Kscore Test

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·RelayPlus Thoracic Stent-Graft System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·RelayPro Thoracic Stent-Graft System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TREO® Abdominal Stent-Graft System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·RelayPro Thoracic Stent-Graft System

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    FDA Pre-Market Approval
    FDA Class 3 ·TRUFILL™ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS