Novadaq Technologies ULC

FDA Device Registration & Listing · Burnaby British Columbia, CA · Registration 3012345110

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012345110
FEI Number
3012345110
Entity Name
Novadaq Technologies ULC
City/State/Country
Burnaby British Columbia, CA
Establishment Address
8329 Eastlake Drive, Unit 101, Burnaby British Columbia V5A 4W2, CA
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190729
PMA Number
N/A

All Registered Proprietary Names

Novadaq Transfer PUREVIEW, ACTIVE LAPAROSCOPIC PLUME FILTRATION DEVICE HIGH FLOW INSUFFLATOR TUBING 16-L INSUFFLATOR TUBING US ADAPTOR FOR UNIVERSAL GAS CONNECTION DISS ADAPTOR FOR UNIVERSAL GAS CONNECTION Novadaq Transfer SPYPHI ARTICULATING ARM TABLE CLAMP SPYPHI ARTICULATING ARM IMAGING HEAD HOLDER SPYPHI ARTICULATING ARM MAIN ARM Novadaq Transfer PINPOINT PAQ (Pack) & Kit PINPOINT Endoscopic Fluorescence Imaging System PINPOINT System Novadaq Transfer HH9006; HH9001 SPY-PHI Handheld Imager SPY-PHI PAQ (Pack) and Kit SPY Portable Handheld Imaging (SPY-PHI) System MP2015A MOLLI OncoPen MT2001 MOLLI 2 Tablet MP2025S MOLLI OncoPen Prime MP2040S MOLLI OncoPen Elite Novadaq Transfer Stryker Carts Connected OR Cart Neurotech Cart SPY Portable Handheld Imaging (SPY-PHI) System SPY-PHI System SPY-PHI Handheld Imager Video Processor / Illuminator VPI Pinpoint Light Cable Stryker Leg Positioner SPYPHI ARTICULATING ARM MAIN ARM SPYPHI ARTICULATING ARM TABLE CLAMP SPYPHI ARTICULATING ARM IMAGING HEAD HOLDER Novadaq Transfer IV Pole THC5 Stand TPS2 Stand Infusion Stand MS -00017 MOLLI Pole Clamp Hydro Pole Mount Novadaq Transfer ND8000 NOVADRAPE SPY PHI STERILE DRAPE HH2000 HH2020 SPY Portable Handheld Imaging (SPY-PHI) System with SPY-PHI Fluorescence Assessment Software SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Fluorescence Assessment Software SPY-PHY Handheld Imager Video Processor / Illuminator VPI Pinpoint Light Cable SPY-QP Fluorescence Assessment Software SPY Portable Handheld Imager/imaging head (SPY-PHI) Video Processor/Illuminator (VPI) SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Transfer SPY-PHI System SPY-PHI Kit SPY Portable Handheld Imaging (SPY-PHI) System SPY-PHI SPY-PHI Pack and Kit HH9006 SPY-PHI Pack Pinpoint Light Cable SPY-PHI Handheld Imager Video Processor/Illuminator (VPI)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-12-14
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2007-06-05
FXR Holder, Camera, Surgical General, Plastic Surgery Class 1 878.4160 2017-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-12-14
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-12-14
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-12-14
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2017-12-14
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2024-10-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-12-14
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2013-06-03
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2020-07-13
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2020-07-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-07-13
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 1989-09-27
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2017-12-14
FOX Stand, Infusion General Hospital Class 1 880.6990 1992-12-15
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2017-12-14
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2020-04-06
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2020-11-06
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2020-11-06
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2023-06-19
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-12-14
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2019-05-21

Official Correspondent

No official correspondent registered.

US Agent Details

April Malmborg Email: april.malmborg@stryker.com Phone: (408) 4093115

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19
K933812 Advanced Surgical, Inc. ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES 1993-12-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012345110. Last updated year: 2026. Please use registration number 3012345110 when referencing this establishment in official correspondence.
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