147 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Canada
×
AMD Medicom Inc.
FDA registration
AMD Medicom Inc.·52 products·🇨🇦 Canada
EMD TECHNOLOGIES INCORPORATED
FDA registration
EMD TECHNOLOGIES INCORPORATED·1 product·🇨🇦 Canada
AMD MEDICOM INC.
FDA registration
AMD MEDICOM INC.·3 products·🇨🇦 Canada
GenomeMe Lab Inc.
Manufacturer
🇨🇦 Canada·2 Importers
AMD Ritmed AssureWear VersaGown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MetaOptima Technology Inc.
Manufacturer
🇨🇦 Canada·1 Importer
bioLytical Laboratories Inc.
Manufacturer
🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S
PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
FDA Enforcement
Class II
·Terminated·PerkinElmer Health Sciences Canada, Inc.·December 5, 2018
DNA Genotek Inc.
Manufacturer
🇨🇦 Canada·10 Basic UDI-DIs·31 Devices·5 Importers
INSTI HIV Self Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV-1/HIV-2 Antibody Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
iSTATIS COVID-19 Ag HOME TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
iSTATIS COVID-19 Ag HOME TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
iSTATIS COVID-19 Ag TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI COVID ANTIBODY TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV ANTIBODY SELF-TEST
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV CONTROL TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV ANTIBODY SELF-TEST
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries