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See the Recall Notice (https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ ucm564092.htm) for a list of affected lot numbers. Distribution Dates: May 7, ...
s June 15, 2017 recall announcement (http://links.govdelivery.com/track?type= click&enid==&&&100&&&https://www.fda.gov/Safety/MedWatch/SafetyInformation ...
FDA is announcing the availability of a draft guidance for industry entitled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations under ...
See the MedWatch Safety Alert (https://www.fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563546.htm) which includes ...
In coordination with the FDA, Teva is extending this recall to the CONSUMER/ USER level. This recall is being carried out due to failing test results for dissolution.
Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential ...
Pfizer is working diligently to restore supply of these products and is in communication with the FDA to address any supply issues. Background: Sodium ...
... 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) is seeking comments on draft revisions to the “FDA Blueprint for Prescriber Education for Extended-Release and ...
The products are being recalled after an Food and Drug Administration (FDA) inspection found significant manufacturing practices that calls into question the ...
The US Food and Drug Administration (FDA) is aware that some health care providers have experienced navigational accuracy errors during surgical ...
... 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), in accordance with the requirements established by the 21st Century Cures Act, has published in the Federal ...
The 21st Century Cures Act became law on December 13, 2016. The Act amends the Food, Drug, and Cosmetic Act (FD&C Act) by removing the requirement for ...
The FDA has classified this as a Class I Recall. This recall accompanies the FDA's Safety Communication from May 17, 2017. Magellan's LeadCare and ...
... of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Resources: * External Links * FDA 2017 Medical Product ...
... of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Resources: * External Links * FDA 2017 Medical Product ...
Read the MedWatch Safety Alert, including a link to the FDA Recall Notice, at the link below. Resources: * External Links * FDA 2017 Medical Product Safety ...
The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. They are conducting studies with the CDC to identify ...
The US Food and Drug Administration (FDA) is informing health care professionals of a Class I recall of the Abbott-Thoratec HeartMate II LVAS Pocket System ...
A US Food and Drug Administration (FDA) review to date has not identified adverse health effects from gadolinium retained in the brain after the use of ...
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. See the Recall Notice for ...
Background The CDC was contacted on April 24, 2017 by the FDA requesting assistance in assessing the potential public health risk of a negative bias ...
The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are warning that certain lead tests manufactured by ...
The US Food and Drug Administration (FDA) is informing healthcare providers of the Class I Recall of ReFlow's Wingman 35 Crossing Catheters due to tip ...
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