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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Septodont currently distributes this device in canada as a class 1 medical device. an internal audit has concluded that this device should be classified as a class 2 medical device. all product in the field will therefore be recalled and commercial sales stopped until the product is licensed appropriately.