Company ยท CA
Novadaq Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2017. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 2017 | K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System Novadaq Technologies, Inc., CA | OWN |
| Sep 20, 2016 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies, Inc., CA | GCJ |
| May 23, 2016 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies, Inc., CA | GCJ |
| Mar 22, 2013 | K123013 | ENDOSCOPIC INTRODUCER Novadaq Technologies, Inc., CA | FED |
| Feb 4, 2011 | K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM Novadaq Technologies, Inc., CA | IZI |
| Jul 9, 2009 | K091515 | SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM Novadaq Technologies, Inc., CA | GCJ |
| Sep 17, 2008 | K081792 | SPY ANALYSIS TOOLKIT, MODEL SA9000 Novadaq Technologies, Inc., CA | LLZ |
| Jan 10, 2008 | K073130 | SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc., CA | IZI |
| Jan 10, 2008 | K073088 | SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc., CA | IZI |
| Nov 9, 2007 | K071619 | SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc., CA | IZI |
| Sep 7, 2007 | K072222 | SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc., CA | IZI |
| May 10, 2007 | K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 Novadaq Technologies, Inc., CA | IZI |
| Jan 12, 2007 | K063345 | SPY IMAGING SYSTEM Novadaq Technologies, Inc., CA | IZI |
| May 3, 2006 | K060867 | SPY INTRAOPERATIVE IMAGING SYSTEM Novadaq Technologies, Inc., CA | IZI |
| Jan 19, 2005 | K042961 | SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 Novadaq Technologies, Inc., CA | IZI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. 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 inten Terminated |
MMP | K041501 |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. 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 sing Terminated |
MMP | K041501 |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. 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 cov Terminated |
MMP | K041501 |
| Aug 18, 2016 | NOVADAQ TECHNOLOGIES INC. 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 Terminated |
IZI | K042961 K060867 +4 |
| Jan 29, 2016 | Novadaq Technologies Inc. PINPOINT Endoscopic Fluorescence Imaging System Terminated |
GCJ | K091515 |
| Dec 1, 2014 | Novadaq Technologies, Inc. Non-sterile drape Terminated |
IZI | K071619 |
| Dec 1, 2014 | Novadaq Technologies, Inc. LUNA Chest, Model No. LU4006 Terminated |
IZI | K071619 |