Novadaq Technologies Ulc. (Now A Part of Stryker): FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Novadaq Technologies Ulc. (Now A Part of Stryker)” (first 2018, latest 2020), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Since 2017 the median was 74 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 61 |
| 2019 | 3 | 95 |
| 2020 | 2 | 73 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Novadaq Technologies Ulc. (Now A Part of Stryker) took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWN | Confocal Optical Imaging | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
Review panels
Most recent Novadaq Technologies Ulc. (Now A Part of Stryker) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | OWN | 2020-11-05 | 87 |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | OWN | 2020-05-21 | 59 |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | OWN | 2019-11-15 | 95 |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) System | OWN | 2019-04-19 | 29 |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | IZI | 2019-01-23 | 98 |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | 2018-11-21 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Novadaq Technologies Ulc. (Now A Part of Stryker).
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Novadaq Technologies, Inc. (15 510(k)s)
- Novadaq Technologies Ulc (A Part of Stryker) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Novadaq Technologies Ulc. (Now A Part of Stryker)?
FDA lists 6 510(k) clearances under the applicant name “Novadaq Technologies Ulc. (Now A Part of Stryker)” (first 2018, latest 2020), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Novadaq Technologies Ulc. (Now A Part of Stryker)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novadaq Technologies Ulc. (Now A Part of Stryker) is 74 days. Since 2017: 74 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Novadaq Technologies Ulc. (Now A Part of Stryker)?
The most frequent FDA product codes under this applicant name are OWN (Confocal Optical Imaging, 4); GCJ (Laparoscope, General & Plastic Surgery, 1); IZI (System, X-Ray, Angiographic, 1).
Next steps
- See all 6 Novadaq Technologies Ulc. (Now A Part of Stryker) clearances with predicates and recalls
- Run predicate analysis for product code OWN, Novadaq Technologies Ulc. (Now A Part of Stryker)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.