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NOVADAQ TECHNOLOGIES INC.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
15
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3235-2017Class IINOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 SingJune 27, 2017
Z-3236-2017Class IINOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, June 27, 2017
Z-3234-2017Class IINOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. ManufJune 27, 2017
Z-2767-2016Class IISterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) TAugust 18, 2016
Z-1032-2016Class IIPINPOINT Endoscopic Fluorescence Imaging SystemJanuary 29, 2016
Z-0469-2015Class IIILUNA Chest, Model No. LU4006November 4, 2014
Z-0470-2015Class IIINon-sterile drapeNovember 4, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemJanuary 11, 2017
K161792PINPOINT Endoscopic Fluorescence Imaging SystemSeptember 20, 2016
K150956PINPOINT Endoscopic Fluorescence Imaging SystemMay 23, 2016
K123013ENDOSCOPIC INTRODUCERMarch 22, 2013
K100371SPY INTRA-OPERATIVE IMAGING SYSTEMFebruary 4, 2011
K091515SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEMJuly 9, 2009
K081792SPY ANALYSIS TOOLKIT, MODEL SA9000September 17, 2008
K073088SPY FLUORESCENT IMAGING SYSTEMJanuary 10, 2008
K073130SPY FLUORESCENT IMAGING SYSTEMJanuary 10, 2008
K071619SPY FLUORESCENT IMAGING SYSTEMNovember 9, 2007
K072222SPY FLUORESCENT IMAGING SYSTEMSeptember 7, 2007
K071037SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000May 10, 2007
K063345SPY IMAGING SYSTEMJanuary 12, 2007
K060867SPY INTRAOPERATIVE IMAGING SYSTEMMay 3, 2006
K042961SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000January 19, 2005