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Getinge did not immediately respond to a Reuters request for comment. The FDA suggests providers to move away from the use of Getinge's Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP ...
Getinge would limit sales of the two products in the U.S. to customers who had no available alternatives, it said. The company has struggled to resolve quality problems with its heart pumps and ...
Maquet GmbH (self-styled as MAQUET) is a multinational German medical technology manufacturing company based in Rastatt [1] [2] with focus on equipment for surgical workplaces, anesthesia systems, workstations for intensive care and cardiovascular devices. [3]
The process of introducing a consent decree begins with negotiation. [5] One of three things happens: a lawsuit is filed and the parties concerned reach an agreement prior to adjudication of the contested issues; a lawsuit is filed and actively contested, and the parties reach an agreement after the court has ruled on some issues; or the parties settle their dispute prior to the filing of a ...
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
(Reuters) -A U.S. federal court issued a decree to restrict the production and sale of Philips' new sleep apnea machines at several facilities in the country, the Food and Drug Administration said ...
Getinge is a global medical technology company, founded in Sweden in 1904. The firm provides equipment and systems within healthcare and life sciences.The company was formerly organised in three business areas: Infection Control (trading as Getinge), Extended Care (ArjoHuntleigh) and Medical Systems (Maquet, the world's largest maker of surgical tables), but announced it would become a single ...
U.S. District Court Approves Invacare Corporation's Consent Decree with the FDA ELYRIA, Ohio--(BUSINESS WIRE)-- Late this afternoon, Invacare Corporation (NYS: IVC) learned that the United States ...