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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In 2009 fda cited cincinnati sub-zero products inc. (csz) for not obtaining proper clearance for the warmair model 135 device fda did not accept csz's rationale for not requiring 510(k) clearance on the device. as a corrective action csz submitted an application for clearance. in october 2010 csz received 510(k) clearance of the warmair 135 device. during the review process however csz made changes to the warmair 135 manual. prior to receiving 510(k) clearance the device was also certified to iec 60601-1-2 which required additional changes to the manual (which were included with the 510(k) submission).