510(k) Report

FDA applicant

Novadaq Technologies Ulc. (Now A Part of Stryker)

Burnaby, CA6 decisions2018–20200 recalls

FDA records 6 decisions for Novadaq Technologies Ulc. (Now A Part of Stryker) (Burnaby, CA) from 2018 to 2020: 6 510(k) clearances. Most are in product codes OWN (Confocal Optical Imaging) and IZI (System, X-Ray, Angiographic). Since 2016 its 510(k)s took a median of 61 days from receipt to decision, against 81 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Novadaq Technologies Ulc. (Now A Part of Stryker)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2018: 12019: 32020: 2
2018high 3 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Novadaq Technologies Ulc. (Now A Part of Stryker) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novadaq Technologies Ulc. (Now A Part…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OWNConfocal Optical Imaging4decisions
  • IZISystem, X-Ray, Angiographic1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 61 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 81 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 201812cite it
  • K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 20194cite it
  • K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 20204cite it
  • K190729SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 20191cites it
  • K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 20191cites it
  • K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 20201cites it

What has FDA decided for it lately?

  • K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
  • K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
  • K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
  • K190729SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
  • K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
  • K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018

All 6 as Novadaq Technologies Ulc. (Now A Part of Stryker) →

Other applicant names beginning “Novadaq”

FDA records each applicant name separately; these may or may not be the same firm.

Novadaq Technologies, Inc. 16Novadaq Technologies Ulc (A Part of Stryker) 1