BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    MEDTRONIC B.V. (EOC)

    Reg #: 3002807561 · FEI: 3002807561 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    MEDTRONIC B.V. (EOC)
    Registration Number
    3002807561
    FEI Number
    3002807561
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    EARL BAKKENSTRAAT 10
    City
    HEERLEN Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K073291
    PMA Number
    P920015

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    Medtronic Sofamor Danek USA, Inc. (Pyramid Place)
    Contact Name
    Michelle Obenauer
    Address
    1800 Pyramid Place
    City
    Memphis
    State
    TN
    ZIP
    38132
    Country
    US
    Email
    [email protected]
    Phone
    901 3992117

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Screwdriver HXX
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Mesh, Surgical, Polymeric FTL
    Tube, Tracheal (W/Wo Connector) BTR
    Permanent Defibrillator Electrodes NVY
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Tube Tracheostomy And Tube Cuff JOH
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Orthosis, Spinal Pedicle Fixation MNI
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Tube, Bronchial (W/Wo Connector) BTS
    Agent, Occluding, Vascular, Permanent PJQ
    Mesh, Surgical FTM
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    CAPSTONE Spinal System SOVEREIGN Spinal System VERTEX® Reconstruction System CD HORIZON® Spinal System SCREWDRIVER Shiley™ CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM BronchoCath with CPAP Parietex™ Hydrophilic 2-Dimensional Mesh SealGuard Evac Tracheal Tubes SealGuard Tracheal Tubes Tube, tracheal (w/wo connector) Adaptor Extender Kit Sprint Quattro Secure MRI SureScan Lead DF-1 Port Pin Plug Subcutaneous Lead Tunneling Tool Sprint Quattro Secure S MRI SureScan Lead Sprint Quattro Secure S Lead Sprint Quattro MRI SureScan Lead Sprint Quattro Lead Transvene Lead Transvene SVC Lead Adaptor Kit IS-1 Port Pin Plug Kit Sprint Quattro Secure Lead Tube tracheostomy and tube cuff CD Perc Trauma M3/M4 Monitor Parietene™ DS Composite Mesh Versatex SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA Shiley™ Extended XLT Pearltene™ Macroporous Mesh Pearltene™ Macroporous Mesh, LPM1515, LPM1515X3, LPM1510, LPM1510X3 Symbotex ProGrip Safety Flex TUBE, BRONCHIAL (W/WO CONNECTOR) VenaSeal™ Closure System Permacol™ Surgical Implant US LaserFlex LASER-FLEX™ TRACHEAL TUBE (CUFFED) Shiley™ Adult Trach. Tubes & Access. SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES General Instrument PASS LP Spinal System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device