BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Covidien llc

    Reg #: 3004904811 · FEI: 3004904811 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Covidien llc
    Registration Number
    3004904811
    FEI Number
    3004904811
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3062 Bunker Hill Lane
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K935198

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Endoscopic Traction Device QSW
    Biopsy Needle FCG
    System, Gastrointestinal Motility (Electrical) FFX
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Esophageal Dilator With Balloon And Electrode Sensors PIE
    Esophageal Dilator Balloon With Or Without Electrode Sensors PID
    Marker, Radiographic, Implantable NEU
    Esophagoscope (Flexible Or Rigid) EOX

    Proprietary Names

    Barrx RFA Endoscopic Guidewire HET Temperature Monitor, HET Bipolar Forceps, HET Reusable Cable ProdiGI BNX Fine Needle Aspiration System HALOFLEX Energy Generator Barrx Flex RFA Energy Generator HALO90 System HALO90 Ablation Catheter Barrx 90 RFA Focal Catheter Flip Topography Module EndoFlip Catheter EndoFlip System HALO90 ULTRA Ablation Catheter Barrx Ultra Long RFA Focal Catheter EsoFLIP ES-330 Beacon Fine Needle Aspiration System Barrx Anorectal RFA Wand Barrx Channel RFA Endoscopic Catheter Endoflip™ 300 System HALO360+ Ablation Catheter and HALO Cap Barrx 360 RFA Balloon Catheter and Barrx RFA Cleaning Cap Barrx 60 RFA Focal Catheter HALO60 Ablation Catheter Barrx 360 Express RFA Balloon Catheter Barrx RFA Self-Sizing Balloon Catheter Beacon Fine Needle Fiducial System Cytosponge Beacon EUS Access System HET™ Bipolar System EsoFlip Catheter ES-310 SharkCore Fine Needle Biopsy System ES-320 HALO360+ Sizing Balloon Barrx 360 Soft Sizing Balloon Barrx SB RFA Endoscopic Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility