Novadaq Technologies, Inc.
Novadaq Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2017, with 7 FDA device recalls on record.
Top product codes for Novadaq Technologies, Inc.
FDA recalls by Novadaq Technologies, Inc.
- 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.
- 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.
- 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.
- 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.
- Z-1032-2016 — PINPOINT Endoscopic Fluorescence Imaging System
- Z-0469-2015 — LUNA Chest, Model No. LU4006
- Z-0470-2015 — Non-sterile drape
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Novadaq Technologies, Inc.
- K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System
- K161792 — PINPOINT Endoscopic Fluorescence Imaging System
- K150956 — PINPOINT Endoscopic Fluorescence Imaging System
- K123013 — ENDOSCOPIC INTRODUCER
- K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM
- K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM
- K081792 — SPY ANALYSIS TOOLKIT, MODEL SA9000
- K073088 — SPY FLUORESCENT IMAGING SYSTEM
- K073130 — SPY FLUORESCENT IMAGING SYSTEM
- K071619 — SPY FLUORESCENT IMAGING SYSTEM
- K072222 — SPY FLUORESCENT IMAGING SYSTEM
- K071037 — SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
- K063345 — SPY IMAGING SYSTEM
- K060867 — SPY INTRAOPERATIVE IMAGING SYSTEM
- K042961 — SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
Data sourced from openFDA. This site is unofficial and independent of the FDA.