10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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AORTIC OCCLUSION SYSTEMS
Device
EU MDR
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Eu Md Class 3
·Front Line Medical Technologies Inc.·On the market·12 countries
COBRA-OS Device
Basic UDI-DI
EU MDR
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Eu Md Class 3
·Front Line Medical Technologies Inc.·1 device
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Enforcement
Class I
·Ongoing·Conavi Medical Inc.·April 30, 2025
Front Line Medical Technologies Inc.
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·2 Importers·Intertek Medical Notified Body AB and Intertek Medical Notified Body AB
Limbus AI Inc.
Manufacturer
🇨🇦 Canada·Kiwa Dare B.V.
SmileSonica Inc.
Manufacturer
🇨🇦 Canada·Intertek Medical Notified Body AB
21M00123CRT01
Certificate
MDR QMS·Limbus AI Inc.·Kiwa Dare B.V.
28620156455
Certificate
MDR QMS·SmileSonica Inc.·Intertek Medical Notified Body AB
28620163227
Certificate
MDR Technical Documentation·Front Line Medical Technologies Inc.·Intertek Medical Notified Body AB
28620163227
Certificate
MDR Technical Documentation·Front Line Medical Technologies Inc.·Intertek Medical Notified Body AB·1 Basic UDI-DI