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Sign in to claim this brandNovadaq Technologies Inc
US
Last updated May 27, 2026
What Novadaq Technologies Inc makes
Novadaq Technologies Inc manufactures rigid optical laparoscopes, laparoscopic surgical procedure kits (non-medicated, single-use), and gastrointestinal endoscopic insufflators. Their portfolio also includes stationary digital fluoroscopic X-ray systems, surgical video cameras, and reusable sterilization packaging. Additional products include medicated general surgical procedure kits, single-use medical drapes, and specialized imaging systems like the SPY-PHI System for fluorescence imaging.
The company’s devices are regulated under FDA pathways, including 510(k) clearances for Class II products and PMA/Premarket Approval applications for Class III devices. Their portfolio is also listed under the FDA’s Unique Device Identification (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.com
- —
- —
- [email protected]
- Phone
- +1(604)232-9861
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 243730939
Catalogue (52)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spy Fluorescent Imaging System | K072222 | FDA 510(k) | Class II | Active |
| Pinpoint Endoscopic Light Source And Video Camera | P950042 | FDA PMA | Class III | Active |
Related Companies
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Novadaq Technologies Inc. has five FDA recall records initiated between January 29, 2016, and June 27, 2017, all of which are marked as terminated. The reasons cited include missing validated sterilization parameters in the PINPOINT Operator’s Manual for certain laparoscopic devices, potential pinholes compromising the sterile integrity of drape materials, and an identified pinhole in the drape pouch film of SK6000 PAQ units during shipping validation.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 27, 2017 | Z-3235-2017 | — | terminated | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| Jun 27, 2017 | Z-3236-2017 | — | terminated | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| Jun 27, 2017 | Z-3234-2017 | — | terminated | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| Aug 18, 2016 | Z-2767-2016 | — | terminated | Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing. |
| Jan 29, 2016 | Z-1032-2016 | — | terminated | It 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. |