BEUDAMED
    2,632 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Hemostasis, Vascular

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

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION)

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·FEM CAP

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

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

    Device, Dermal Replacement

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ARRAY MULTIFOCAL ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ALLERGAN SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·ETHICON OMNEX SURGICAL SEALANT

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL'S

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·OVATION ABDOMINAL STENT GRAFT SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Medical Adhesive Model 6517

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Lead Repair Kit Model 6946

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·Adherus AutoSpray Dural and ET Dural Sealant

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere (comfilcon A), Biofinity Toric

    Scaffold, Infrapopliteal, Absorbable

    FDA Pre-Market Approval
    FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ZYDERM/ZYPLAST COLLAGEN, COSMODERM/ COSMOPLAST HUMAN COLLAGEN IMPLANT

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biomedics 55 Asphere (ocufilcon D), Biomedics Torie (ocufilcon D) Soft (Hydrophilic) Contact Lenses for extended wear

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere (comfilcon A), Biofinity Torie (comfilcon A), Biofinity XR Torie (comfilcon A), Biofinity Torie Multifo