6 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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Ora Medical Inc.
Manufacturer
🇨🇦 Canada·2 Importers
ORA MEDICAL INC
FDA registration
ORA MEDICAL INC·1 product·🇨🇦 Canada
ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
FDA Enforcement
Class II
·Terminated·Baylis Medical Corp *·April 22, 2015
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
FDA Enforcement
Class II
·Terminated·Baylis Medical Corp *·December 9, 2015
OxyMask O2 Adult REF OM-1125-14
FDA Enforcement
Class II
·Ongoing·Southmedic, Inc.·August 4, 2021
FloPatch FP120, REF: FP120-FOT01-005
FDA Enforcement
Class III
·Ongoing·Flosonics Medical (R/A 1929803 ONTARIO CORP.)·September 10, 2025