9 results
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27ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
FDA Enforcement
Class II
·Terminated·LABORIE MEDICAL TECHNOLOGIES, CANADA ULC·July 15, 2020
Baylis Medical Company Inc.
Manufacturer
🇨🇦 Canada·1 Importer
HOLDER, DENTAL BUR, ALUMINUM
FDA 510(k)
FDA Class 2
·Dental
F.G. LASER (DENTAL BUR)
FDA 510(k)
FDA Class 1
·Dental
GluStitch Inc.
Manufacturer
🇨🇦 Canada·1 Basic UDI-DI·3 Devices·2 Importers
PeriAcryl®90 HV Cyanoacrylate Oral Adhesive
Device
EU MDR
·
Eu Md Class 1
·GluStitch Inc.·On the market·13 countries
PeriAcryl®90
Device
EU MDR
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Eu Md Class 1
·GluStitch Inc.·On the market·13 countries
PeriAcryl®90
Device
EU MDR
·
Eu Md Class 1
·GluStitch Inc.·On the market·13 countries
PeriAcryl®90
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·GluStitch Inc.·3 devices