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The FDA hit Draeger Medical Systems with a warning letter for failing to submit a new 510(k) premarket notification for “significant changes” it made to its patient monitoring device. Read More
Devicemaker Guy & O’Neill of Fredonia, Wisconsin fell short on design validation, written procedures for design control and procedures to control product that did not conform to specifications during an FDA inspection. Read More
Failure to develop numerous quality system practices such as medical device reporting procedures, corrective and preventive actions procedures, and procedures for acceptance of incoming product resulted in an FDA Form 483 for devicemaker Polyconversions following an inspection of its Champaign, Illinois plant. Read More
Failure to develop written medical device reporting procedures, complaint handling procedures, corrective and preventive action procedures landed devicemaker Health Science Products in hot water with the FDA following an inspection of its Hueytown, Alabama facility. Read More
The FDA hit Draeger Medical Systems with a warning letter for failing to submit a new 510(k) premarket notification for “significant changes” it made to its patient monitoring device. Read More
The changes the company made to its multi-parameter monitoring system could impact its safety and effectiveness and lead to patient injury or death, the agency warned. Read More