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Medtronic Plc (NYSE:MDT) has initiated a recall for some versions of its StealthStation S8 application. The FDA deemed software recall as Class I, the most serious kind. The medical device giant ...
Medtronic operational headquarters in Fridley, Minnesota, a suburb of Minneapolis. Medtronic was founded in 1949 in Minneapolis by Earl Bakken and his brother-in-law, Palmer Hermundslie, as a medical equipment repair shop. [8] Bakken invented several medical technology devices that continue to be used around the world today. [citation needed]
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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
In 1991, Medtronic and Mirowski entered into an agreement permitting Medtronic to practice certain Mirowski patents in exchange for royalty payments. In 2007, the parties found themselves in the midst of an "infringement" dispute, and Mirowski gave Medtronic notice that it believed seven new Medtronic products violated various claims contained in two of its patents, [a] which dealt with ...
Product recalls are one of a number of corrective actions that can be taken for products that are deemed to be unsafe. The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can cause significant legal costs. It can be difficult, if not impossible, to determine how costly can be ...
The FDA has given 510(k) clearance for Conformis Inc's (NASDAQ: CFMS) Identity Imprint Knee Replacement System, available in both cruciate-retaining (CR) and posterior stabilized (PS) versions.