Novadaq Technologies ULC
Burnaby British Columbia, CA
Novadaq Technologies ULC appears in FDA device records in Burnaby British Columbia, CA. FDA records list 15 510(k) clearances between and , 5 PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Novadaq Technologies ULC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Novadaq Technologies, Inc.510(k), PMA, enforcement report, recall
510(k) clearance history
FDA records hold 15 510(k) clearances for Novadaq Technologies ULC between 2005 and 2017. The busiest year on record is 2007, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | OWN | Substantially Equivalent | |
| K161792 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | Substantially Equivalent | |
| K150956 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | Substantially Equivalent | |
| K123013 | ENDOSCOPIC INTRODUCER | FED | Substantially Equivalent | |
| K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K091515 | SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM | GCJ | Substantially Equivalent | |
| K081792 | SPY ANALYSIS TOOLKIT, MODEL SA9000 | LLZ | Substantially Equivalent | |
| K073130 | SPY FLUORESCENT IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K073088 | SPY FLUORESCENT IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K071619 | SPY FLUORESCENT IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K072222 | SPY FLUORESCENT IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 | IZI | Substantially Equivalent | |
| K063345 | SPY IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K060867 | SPY INTRAOPERATIVE IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K042961 | SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 | IZI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012345110 | 3012345110 | Novadaq Technologies ULC | 8329 Eastlake Drive, Unit 101, Burnaby British Columbia V5A 4W2 CA | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- OWNConfocal Optical Imaging
- PUIDrape, Surgical, Exempt
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FXRHolder, Camera, Surgical
- GCJLaparoscope, General & Plastic Surgery
- NEUMarker, Radiographic, Implantable
- FWZOperating Room Accessories Table Tray
- FOXStand, Infusion
- LLZSystem, Image Processing, Radiological
- MRKSystem, Imaging, Fluorescence
- IZISystem, X-Ray, Angiographic
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3236-2017 | NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact. | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. | Class II | Terminated | |
| Z-3235-2017 | NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact. | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. | Class II | Terminated | |
| Z-3234-2017 | NOVADAQ 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 maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact. | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. | Class II | Terminated | |
| Z-2767-2016 | Sterile 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 vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery. | 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. | Class II | Terminated | |
| Z-1032-2016 | PINPOINT Endoscopic Fluorescence Imaging System | 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. | Class II | Terminated | |
| Z-0470-2015 | Non-sterile drape | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. | Class III | Terminated | |
| Z-0469-2015 | LUNA Chest, Model No. LU4006 | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. | Class III | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain