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The FDA said ResMed was recalling these masks to update the labels and add more warnings and information. The California-based medical device maker started the recall process on Nov. 20 and has ...
The FDA defines a recall as a method of removing or correcting products that are in violation of laws administered by the health regulator and does not include a market withdrawal. ResMed's masks ...
ResMed Inc. is an American medical equipment company based in San Diego, California.It primarily provides cloud-connectable medical devices for the treatment of sleep apnea (such as CPAP devices and masks), chronic obstructive pulmonary disease (COPD), and other respiratory conditions.
The full U.S. launch of ResMed (RMD) AirSense 11 is expected any time in 2021, which might receive bigger market acceptance capitalizing on its current peer position.
A product recall is a request from a manufacturer to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker or seller at risk of legal action. Product recalls are one of a number of corrective actions that can be taken for products that are deemed to be unsafe.
Bag valve mask. Part 1 is the flexible mask to seal over the patients face, part 2 has a filter and valve to prevent backflow into the bag (prevents patient deprivation and bag contamination) and part 3 is the soft bag element which is squeezed to expel air to the patient
The emergence of two prominent COVID variants—BA.2.86 and EG.5—have left many wondering whether mask mandates will be reinstated by the CDC. See what to know.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.