In many cases, establishments are removed due to a failure to renew annual registration with the agency.
The Banyan Brain Trauma Indicator was authorized through the agency’s Breakthrough Devices Program.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
You must respond within 15 days, and you must show FDA how your establishment will be brought back to compliance.
A manufacturing error could cause chamber parts to split into layers and cause water to back up into the patient breathing circuit.
FDA requires that manufactures establish and maintain procedures regarding labeling activities.
The program aims to ensure that life-saving devices are available in battlefield settings.
The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.
Failing to report serious patient injuries will win you a warning letter.
The program intends to promote quality in medical device design and manufacturing.