Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Until conducted by health canada on may 202013 the avatar sc-5 was marketed as a scientific instrument. the product was classified in concurrence with the medical devices bureau as a class ii medical device by rule 10(1) of the regulations. the product has not been marketed and sold in full compliance with the requirements of the food and drugs act and medical devices regulations.