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33 States Suing over 5-Hour Energy Drink

08/13/2014
Articles
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Oregon, Washington State and Vermont say the slogans for 5-Hour Energy drink are hype that is misleading. Last week the Attorneys General of all three states filed lawsuits against the drink’s maker, Living Essentials LLC and Innovation Ventures LLC of Farmington Hills, Michigan. They are seeking civil penalties against the […]

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Morcellator: Johnson & Johnson Recalls Device

08/7/2014
Announcement
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Morcellator is a surgical instrument sold under the name of Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract, and which are used for division and removal of large masses of tissues during laparoscopic surgery.  Morcellators are also used in minimally invasive surgery to perform hysterectomies and in the removal of uterine […]

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FDA Issues Draft Guidance on 510(k)

08/4/2014
Articles
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The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued guidances are non-binding and only “represent the Food and Drug Administration’s current thinking […]

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Study Supports FDA Warning About Power Morcellator

07/29/2014
Articles
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The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of debate since the Food and Drug Administration discouraged its use in April. A study by doctors at Columbia University, published […]

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