The tests in a green and white box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
These tests have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
The tests in a dark blue box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
Regular clinical follow-up and imaging is critical to detect EVAR device and treatment failures.
Arrow International, LLC is recalling its Arrow-Trerotola Percutaneous Thrombolytic Device due to potential tip damage during use.
E25Bio COVID-19 Direct Antigen Rapid Tests are being recalled because they are not authorized, cleared, or approved for use by the FDA.
Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration set setup and/or incomplete resolution of upstream occlusi
BASE10 Genetics RNAstill MTM specimen collection kits are being recalled because they are not FDA-authorized, -cleared, or -approved for use.
Family Dollar,
Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the pre
There is an issue with bellavista 1000 and 1000e ventilators with software version 6.0.1600.0 or higher installed and have the Data Communication port set to “HL7."
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