Aesculap Inc. Surgical Instrument Sets

Issue

AIC has become aware of the sales and distribution of certain medical devices into the Canadian market without a medical device license from Health Canada. Please note that while devices were unlicensed, the patient safety assessment took into consideration a number of factors, including low number of adverse events (if any) in Canada and globally, relationship of these devices to licensed devices (e.g. accessories to licensed devices being sold without an individual license), similarity to other devices licensed in Canada, and medical device licensing status in other jurisdictions, all of which supports that these devices meet applicable requirements for safety and efficacy.