Policy Library Results:
Search results for: "fda"
13 results (showing 1 through 13)
Blunt-tip Suture Needles: Central Service FDA regulated suture needle that is not as sharp as standard (sharp-tip) suture needles and are designed to penetrate ...
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REFERENCE: US Food and Drug Administration (FDA), Medical Devices, Products and Medical Procedures, Device Approvals and Clearances, Device ...
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The FDA has received reports of medical equipment malfunctions caused by EMI which include, but are not limited to: Pacemakers - in the presence of radio ...
Burden of evaluating devices and proving effectiveness is on the employer. CRITERIA TO SELECT SAFETY DEVICES: The FDA suggests the following criteria ...
StayAlert Results:
Search results for: "fda"
3005 results (showing 1 through 25)
The FDA has classified this a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Follow the link below for ...
The FDA has been notified and is aware Oscor Inc. is voluntarily taking this action . According to the recall notice, during the use of some TB - Temporary Bipolar ...
In a new safety communication, the US Food and Drug Administration (FDA) is providing recommendations and sharing important information with health care ...
The US Food and Drug Administration (FDA) is proposing to amend its regulations to implement a provision of the 21st Century Cures Act and add an exception ...
... of this product may be reported to FDA's MedWatch Adverse Event Reporting program. Resources: * External Links * FDA 2018 Medical Product Safety Alert.
During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production ...
The US Food and Drug Administration (FDA) is providing an update about the potential for unintended heating and patient injury with use of the Monteris ...
The US Food and Drug Administration (FDA) is alerting patients and health care providers that claims for many genetic tests to predict a patient's response to ...
This recall is being conducted with the knowledge of the US Food and Drug Administration. Resources: * External Links * FDA 2018 Medical Product Safety ...
The US Food and Drug Administration (FDA) is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and ...
... contact Roche Diagnostics at 1-800-428-4674 to learn more details about the recall. Resources: * External Links * FDA 2018 Medical Product Safety Alert.
The US Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down ...
ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots (https://www.fda. gov/Safety/Recalls/ucm624547.htm?utm_campaign=Aurobindo%20Pharma% ...
The US Food and Drug Administration (FDA) is providing additional information regarding corneal endothelial cell loss in patients who have received the Alcon ...
The US Food and Drug Administration (FDA) has issued a safety communication to alert eye care providers and patients already implanted with the device of the ...
... MedWatch Adverse Event Reporting program. Follow the link below for additional information. Resources: * External Links * FDA 2018 Medical Product Safety ...
Since issuing that October 2015 communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated ...
Recalled Product(s): * Endologix AFX Endovascular AAA System * Model/Item Numbers: See "Full List of Affected Devices (https://www.fda.gov/MedicalDevices/ ...
The Center for Biologics Evaluation and Research (CBER), a division of the Food & Drug Administration (FDA), which oversees human cells and tissue-based ...
The US Food and Drug Administration (FDA) has issued a safety communication with cybersecurity updates affecting medtronic implantable cardiac device ...
Here is a table (https://www.cdc.gov/flu/professionals/acip/2018-2019/2018- 19summary.htm#iivs) showing all flu vaccines that are FDA-approved for use in the ...
... including a full listing of recalled product and model numbers and product photos. Resources: * External Links * FDA 2018 Medical Product Safety Alert.
The US Food and Drug Administration (FDA) has received reports of dosing errors and confusion with the labeled strength expression for certain compounded ...
The US Food and Drug Administration (FDA) has classified this as a Class I recall , the most serious type of recall: use of these devices may cause serious ...
... PM Eastern Standard Time, or pmi.us@pmisurgial.com (mailto:pmi.us@ pmisurgial.com). Resources: * External Links * FDA 2018 Medical Product Safety Alert.
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