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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Sale of unlicensed class ii medical devices. the affected products were originally classified as by bte as class i medical devices. recentlythe devices were classified as class ii medical devices and appropriate class ii licensing was not in place and license numbers are not listed on product labels.