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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The pyloritek product sold to customers in canada was not licensed in accordance with the canadian medical device regulations. the error in the classification of the pyloritek product was found during the regulatory inspection performed off-site by teleconference on september 26 2016.