142 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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Coroneo Inc.
Manufacturer
🇨🇦 Canada·49 Basic UDI-DIs·49 Devices·2 Importers·GMED SAS and GMED SAS
MY01 Inc.
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·4 Devices·1 Importer·GMED SAS
Meditech International Inc
Manufacturer
🇨🇦 Canada·18 Basic UDI-DIs·18 Devices·1 Importer·GMED SAS
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
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.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·September 14, 2016
Luméd inc.
Manufacturer
🇨🇦 Canada·1 Importer
Extra Aortic
Device
EU MDD
·
Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
Extra Aortic
Device
EU MDD
·
Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
Extra Aortic
Device
EU MDD
·
Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
Extra Aortic
Device
EU MDD
·
Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
THORACIC SURGERY INSTRUMENTS, REUSABLE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·5 countries
COR-VALV Atrial retractor
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·11 countries
THORACIC SURGERY INSTRUMENTS, REUSABLE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·5 countries
THORACIC SURGERY INSTRUMENTS, REUSABLE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·5 countries
THORACIC SURGERY INSTRUMENTS, REUSABLE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·7 countries
COR-VALV
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·4 countries
COR-VALV
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·10 countries
Swift Loop
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·1 country
COR-VALV
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·11 countries
Swift Loop
Device
EU MDD
·
Eu Md Class 2a
·Coroneo Inc.·On the market·8 countries