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319 results (showing 1 through 25)
This recall notice updates the Food and Drug Administration (FDA)'s October 2016 recall notice about St. Jude Medical's Implantable Cardioverter Defibrillators ...
... of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Resources: * External Links * FDA 2017 Medical Product ...
The US Food and Drug Administration (FDA) received an adverse event report on August 14, 2017, from a physician concerning a patient who was diagnosed ...
The US Food and Drug Administration (FDA) has updated three final guidances, including Form FDA 3926 and its instructions, to simplify Institutional Review ...
The US Food and Drug Administration ( FDA) is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called ...
OriGen Biomedical has notified the FDA of this action.OriGen Biomedical is aware of two (2) product failures and has received a complaint associated with each ...
The US Food and Drug Administration (FDA) has issued an update to the October 2016 letter to healthcare providers about the TAH-t Companion 2 Driver ...
Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units. If a device with a ...
The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with ...
The US Food and Drug Administration (FDA), based on additional review, is advising that the opioid addiction medications buprenorphine and methadone ...
... of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Resources: * External Links * FDA 2017 Medical Product ...
See the press release (http://links.govdelivery.com/track?type=click&enid== &&&100&&&https://www.fda.gov/Safety/Recalls/ucm575731.htm?source= ...
On September 5, 2017, the US Food and Drug Administration (FDA) issued a warning letter to a Meridian Medical Technologies facility, located in Brentwood, ...
The US Food and Drug Administration (FDA) has issued final guidance for industry and FDA staff outlining FDA's expectations and recommendations for the ...
The US Food and Drug Administration (FDA) is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate ...
See the Recall Notice for a complete list of product lot numbers affected by this recall. Resources: * External Links * FDA 2017 Medical Product Safety Alert.
Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra- Aortic Balloon Pumps manufactured July 1, 2003 to June 16, 2017 due to False ...
Follow the link below for additional information, including photos of the recalled product. Resources: * External Links * FDA 2017 Medical Product Safety Alert.
The FDA initially contacted Foshan on May 25, 2017, regarding a recall, and had several follow-up meetings with the company. However, Foshan has not taken ...
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, ...
The US Food and Drug Administration (FDA) is reminding health care providers that using thermoregulation devices during surgery, including forced air ...
The FDA statement is based on review of data from two clinical trials (KEYNOTE- 183 and KEYNOTE-185) evaluating the use of Keytruda (pembrolizumab) ...
On August 23, 2017, the US Food and Drug Administration (FDA) approved a firmware update that is now available and is intended as a recall, specifically a ...
... of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Resources: * External Links * FDA 2017 Medical Product ...
Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA ...
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