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Novadaq Technologies Inc

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(604)232-9861
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 243730939

Catalogue (52)

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Device	Model / Reference	Registries	Class	Status
SPY-PHI System	HH9001	FDA UDI	Class II	Active
Spy®	ND3010	FDA UDI	N/A	Unknown
NOVADAQ®and PINPOINT®	SC9140	FDA UDI	Class II	Unknown
Pinpoint	PC9002	FDA UDI	Class II	Active
NOVADAQ and PINPOINT	SC9144	FDA UDI	Class II	Active
Pinpoint	PC9004	FDA UDI	Class II	Active
SPY-PHI System	HH9000	FDA UDI	Class II	Active
NOVADAQ®and PINPOINT®	SC9101	FDA UDI	Class II	Unknown
Spy	SK6000	FDA UDI	Class II	Unknown
Pinpoint Paq®	PP9096	FDA UDI	N/A	Active
NOVADAQ®and PINPOINT®	SC9131	FDA UDI	Class II	Unknown
Novadrape®	ND8000	FDA UDI	N/A	Unknown
Spy	LC3000	FDA UDI	Class II	Active
NOVADAQ and PINPOINT	PC9000	FDA UDI	Class II	Active
NOVADAQ®and PINPOINT®	SC9100	FDA UDI	Class II	Unknown
Luna Paq®	LU3001	FDA UDI	N/A	Active
NOVADAQ®and PINPOINT®	PP9062	FDA UDI	Class II	Unknown
NOVADAQ and PINPOINT	SC9534	FDA UDI	Class II	Active
NOVADAQ®and PINPOINT®	PP9063	FDA UDI	Class II	Active
NOVADAQ and PINPOINT	SC9544	FDA UDI	Class II	Active
NOVADAQ and PINPOINT	SC9504	FDA UDI	Class II	Active
SPY-Q™ or SPY-QCM™	SQ3500	FDA UDI	Class II	Active
Luna	LU3000	FDA UDI	Class II	Active
NOVADAQ®and PINPOINT®	PC9017	FDA UDI	Class II	Active
Pinpoint Paq®	PP9050	FDA UDI	Class II	Active
NOVADAQ®and PINPOINT®	PC9018	FDA UDI	Class II	Active
Spy Paq	LC3006	FDA UDI	Class II	Active
The Heart Laser Disposable TMR kit	AC00012	FDA UDI	Class III	Unknown
SPY-PHI System	HH2000	FDA UDI	N/A	Active
NOVADAQ and PINPOINT	SC9134	FDA UDI	Class II	Active
NOVADAQ and PINPOINT	SC9104	FDA UDI	Class II	Active
Pinpoint Paq®	PP9092	FDA UDI	N/A	Unknown
NOVADAQ®and PINPOINT®	SC9130	FDA UDI	Class II	Unknown
Pinpoint Paq	PP9031	FDA UDI	Class II	Active
NOVADAQ®and PINPOINT®	PC9061	FDA UDI	Class II	Active
Spy Paq®	SK6000	FDA UDI	N/A	Unknown
Spy Intraoperative Imaging System	K060867	FDA 510(k)	Class II	Active
Spy Analysis Toolkit, Model Sa9000	K081792	FDA 510(k)	Class II	Active
Spy Fluorescent Imaging System	K073088	FDA 510(k)	Class II	Active
PINPOINT Endoscopic Fluorescence Imaging System	K150956	FDA 510(k)	Class II	Active
SPY Phi Open Field Handheld Fluorescence Imaging System	K162885	FDA 510(k)	Class II	Active
PINPOINT Endoscopic Fluorescence Imaging System	K161792	FDA 510(k)	Class II	Active
Spy Fluorescent Imaging System	K071619	FDA 510(k)	Class II	Active
Spy Intra-Operative Imaging System	K100371	FDA 510(k)	Class II	Active
Spy Intra-Operative Imaging System: Sp2000	K042961	FDA 510(k)	Class II	Active
Spy Imaging System	K063345	FDA 510(k)	Class II	Active
Spy Scope Intra-Operative Operating System	K091515	FDA 510(k)	Class II	Active
Endoscopic Introducer	K123013	FDA 510(k)	Class II	Active
Spy Intra-Operative Imaging System, Model Sp2000	K071037	FDA 510(k)	Class II	Active
Spy Fluorescent Imaging System	K073130	FDA 510(k)	Class II	Active

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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.