![]() § 351(f)(1)(B), because your firm does not have, for the particular uses described below, an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. The FDA has reviewed your firm’s websites (and ) and determined that certain claims on those websites have caused the CardioHelp System to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. Maquet specializes in solutions, therapies and products for surgical interventions, interventional cardiology and intensive care. Getinge provides solutions for infection control within healthcare and contamination prevention within life sciences. ![]() ArjoHuntleigh focuses on patient mobility and wound management solutions. ![]() We operate under the three brands of ArjoHuntleigh, Getinge and Maquet. Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. ![]()
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