Novadaq Technologies, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Novadaq Technologies, Inc.” (first 2005, latest 2017), plus 1 PMA decision, across 6 product codes in 4 review panels. Median 510(k) review time under this name: 82 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 175 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 246 |
| 2017 | 1 | 86 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 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, Inc. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | 9 | 9 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MRK | System, Imaging, Fluorescence | 1 | 0 |
| OWN | Confocal Optical Imaging | 1 | 1 |
Review panels
- Radiology (10)
- General and Plastic Surgery (4)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
Most recent Novadaq Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | OWN | 2017-01-11 | 86 |
| K161792 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | 2016-09-20 | 82 |
| K150956 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | 2016-05-23 | 410 |
| K123013 | ENDOSCOPIC INTRODUCER | FED | 2013-03-22 | 175 |
| K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM | IZI | 2011-02-04 | 357 |
| K091515 | SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM | GCJ | 2009-07-09 | 48 |
| K081792 | SPY ANALYSIS TOOLKIT, MODEL SA9000 | LLZ | 2008-09-17 | 84 |
| K073130 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2008-01-10 | 65 |
| K073088 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2008-01-10 | 70 |
| K071619 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2007-11-09 | 149 |
5 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P950042 | PMA | PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA | 1996-09-19 |
Recalls
7 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2017-06-27.
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 Ulc. (Now A Part of Stryker) (6 510(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, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Novadaq Technologies, Inc.” (first 2005, latest 2017), plus 1 PMA decision, across 6 product codes in 4 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novadaq Technologies, Inc. is 82 days.
Which FDA product codes appear under Novadaq Technologies, Inc.?
The most frequent FDA product codes under this applicant name are IZI (System, X-Ray, Angiographic, 9); GCJ (Laparoscope, General & Plastic Surgery, 3); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1).
Next steps
- See all 15 Novadaq Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZI, Novadaq Technologies, Inc.'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.