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    FDA Registration Active 🇨🇦 Canada

    Novadaq Technologies ULC

    Reg #: 3012345110 · FEI: 3012345110 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    71
    Establishment Types
    6
    Classifications
    13

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    Registration Details

    Registration Name
    Novadaq Technologies ULC
    Registration Number
    3012345110
    FEI Number
    3012345110
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8329 Eastlake Drive, Unit 101
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K123013

    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
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Holder, Camera, Surgical FXR
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Confocal Optical Imaging OWN
    Marker, Radiographic, Implantable NEU
    System, Image Processing, Radiological LLZ
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Operating Room Accessories Table Tray FWZ
    Wrap, Sterilization FRG
    Stand, Infusion FOX
    Drape, Surgical, Exempt PUI

    Proprietary Names

    Novadaq Transfer PUREVIEW, ACTIVE LAPAROSCOPIC PLUME FILTRATION DEVICE HIGH FLOW INSUFFLATOR TUBING 16-L INSUFFLATOR TUBING US ADAPTOR FOR UNIVERSAL GAS CONNECTION DISS ADAPTOR FOR UNIVERSAL GAS CONNECTION SPYPHI ARTICULATING ARM TABLE CLAMP SPYPHI ARTICULATING ARM IMAGING HEAD HOLDER SPYPHI ARTICULATING ARM MAIN ARM PINPOINT PAQ (Pack) & Kit PINPOINT Endoscopic Fluorescence Imaging System PINPOINT System HH9006; HH9001 SPY-PHI Handheld Imager SPY-PHI PAQ (Pack) and Kit SPY Portable Handheld Imaging (SPY-PHI) System MP2015A MOLLI OncoPen MT2001 MOLLI 2 Tablet MP2025S MOLLI OncoPen Prime MP2040S MOLLI OncoPen Elite Stryker Carts Connected OR Cart Neurotech Cart SPY-PHI System Video Processor / Illuminator VPI Pinpoint Light Cable Stryker Leg Positioner IV Pole THC5 Stand TPS2 Stand Infusion Stand MS -00017 MOLLI Pole Clamp Hydro Pole Mount ND8000 NOVADRAPE SPY PHI STERILE DRAPE HH2000 HH2020 SPY Portable Handheld Imaging (SPY-PHI) System with SPY-PHI Fluorescence Assessment Software SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Fluorescence Assessment Software SPY-PHY Handheld Imager SPY-QP Fluorescence Assessment Software SPY Portable Handheld Imager/imaging head (SPY-PHI) Video Processor/Illuminator (VPI) SPY-PHI Kit SPY-PHI SPY-PHI Pack and Kit HH9006 SPY-PHI Pack MP2001 MOLLI 2 Wand MOLLI 2 LC3006 SPY Elite System SPY Elite SPY Elite Pack & Kit SPY Elite Intraoperative Perfusion Assessment System PINPOINT Lymphatics Kit PP9036 PINPOINT Kit PP9037 PINPOINT Lymphatics Pack PINPOINT Pack SPY-MIS Pack SPY-MIS Kit Pinpoint Laparoscope - 10mm, Standard, 0 with Wolf and Storz adaptor Pinpoint Laparoscope - 5mm, Standard, 30 with Wolf and Storz adaptor Pinpoint Laparoscope - 10mm, Standard, 45 with Wolf and Storz adaptor Pinpoint Camera Head Pinpoint Laparoscope - 5mm, Standard, 0 with Wolf and Storz adaptor Pinpoint Laparoscope - 10mm, Standard, 30 with Wolf and Storz adaptor Pinpoint Laparoscope - 5mm, Standard, 45 with Wolf and Storz adaptor

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198