BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SPY Elite Intraoperative Perfusion Assessment System

    Reg #: 3012345110 · FEI: 3012345110 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Novadaq Technologies ULC
    Registration Number
    3012345110
    FEI Number
    3012345110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8329 Eastlake Drive, Unit 101
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K182907

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI

    Proprietary Names

    SPY Elite Intraoperative Perfusion Assessment System SPY Elite SPY Elite Pack & Kit LC3006 SPY Elite System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198