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Data / Medical devices / Canada / Novadaq Technologies ULC

Novadaq Technologies ULC: FDA-registered device maker in Burnaby British Columbia, Canada, 17 510(k) clearances

Novadaq Technologies ULC is registered with the FDA (registration 3012345110) in Burnaby British Columbia, Canada. It lists 13 device types. The FDA files 17 510(k) clearances under its listings, the newest dated May 28, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Novadaq Technologies ULC
FDA registration number
3012345110
Address
8329 Eastlake Drive, Unit 101, Burnaby British Columbia, Canada, V5A 4W2
Owner or operator
STRYKER CORP. (1811755)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
September 27, 1989
Registered through
2027
Brand names listed
16-L INSUFFLATOR TUBING, 1788090000 780 nm SPY-PHI Camera Control Unit, 1788910105 780 nm SPY-PHI Imager, 220240305: 780 nm SPY-PHI Light Source, Connected OR Cart, DISS ADAPTOR FOR UNIVERSAL GAS CONNECTION, HH2000, HH2020 and more

Devices it lists

DeviceProduct codeClassRoleSource
Cart, Emergency, Cardiopulmonary (Excluding Equipment)BZN1Specification developeraccessdata.fda.gov
Confocal Optical ImagingOWN2Complaint file establishment, Manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Manufactureraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Repackager or relabeleraccessdata.fda.gov
Holder, Camera, SurgicalFXR1Exporter to the US, Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Marker, Radiographic, ImplantableNEU2Contract manufactureraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Exporter to the USaccessdata.fda.gov
Stand, InfusionFOX1Contract manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Exporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 28, 2026K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZISubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
June 5, 2023K230727SPY Portable Handheld Imaging (SPY-PHI) SystemIZISubstantially EquivalentNovadaq Technologies Ulc (A Part of Stryker)accessdata.fda.gov
November 5, 2020K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareOWNSubstantially EquivalentNovadaq Technologies Ulc. (Now A Part of Stryker)accessdata.fda.gov
May 21, 2020K200737SPY Portable Handheld Imaging (SPY-PHI) SystemOWNSubstantially EquivalentNovadaq Technologies Ulc. (Now A Part of Stryker)accessdata.fda.gov
November 15, 2019K192174SPY Portable Handheld Imaging (SPY-PHI) SystemOWNSubstantially EquivalentNovadaq Technologies Ulc. (Now A Part of Stryker)accessdata.fda.gov
April 19, 2019K190729SPY Portable Handheld Imaging (SPY-PHI) SystemOWNUnknownNovadaq Technologies Ulc. (Now A Part of Stryker)accessdata.fda.gov
January 23, 2019K182907SPY Elite Intraoperative Perfusion Assessment SystemIZISubstantially EquivalentNovadaq Technologies Ulc. (Now A Part of Stryker)accessdata.fda.gov
November 21, 2018K182606PINPOINT Endoscopic Fluorescence Imaging SystemGCJSubstantially EquivalentNovadaq Technologies Ulc. (Now A Part of Stryker)accessdata.fda.gov
January 11, 2017K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemOWNSubstantially EquivalentNovadaq Technologies, Inc.accessdata.fda.gov
September 20, 2016K161792PINPOINT Endoscopic Fluorescence Imaging SystemGCJSubstantially EquivalentNovadaq Technologies, Inc.accessdata.fda.gov
May 23, 2016K150956PINPOINT Endoscopic Fluorescence Imaging SystemGCJSubstantially EquivalentNovadaq Technologies, Inc.accessdata.fda.gov
March 22, 2013K123013ENDOSCOPIC INTRODUCERFEDSubstantially EquivalentNovadaq Technologies, Inc.accessdata.fda.gov
July 9, 2009K091515SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEMGCJSubstantially EquivalentNovadaq Technologies, Inc.accessdata.fda.gov
December 5, 2008K080558STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTSFRGSubstantially EquivalentCase Medical, Inc.accessdata.fda.gov
September 17, 2008K081792SPY ANALYSIS TOOLKIT, MODEL SA9000LLZSubstantially EquivalentNovadaq Technologies, Inc.accessdata.fda.gov
January 10, 2008K073088SPY FLUORESCENT IMAGING SYSTEMIZISubstantially EquivalentNovadaq Technologies, Inc.accessdata.fda.gov
May 9, 2003K022978STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTSFRGSubstantially EquivalentCase Medical, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 27, 201777901Class IITerminatedNOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to mThe sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.accessdata.fda.gov
August 18, 201675006Class IITerminatedSterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessNovadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.accessdata.fda.gov
January 29, 201673225Class IITerminatedPINPOINT Endoscopic Fluorescence Imaging SystemIt has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.accessdata.fda.gov

Compare with other makers

Updated May 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.