11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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SPY-PHI System with SPY-PHI Fluorescence Assessment Software
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Radiology
SPY Phi Open Field Handheld Fluorescence Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 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.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 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.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017
Sekisui Diagnostics PEI Inc
Manufacturer
🇨🇦 Canada
The Orthotic Group, Inc.
Manufacturer
🇨🇦 Canada