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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Terumo cvs has determined that the updated information in the operator's manual would improve patient safety by mitigating any ambiguity and by providing accurate performance ranges that align with device operation. updated labeling will be provided to users in the field.