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FDA Medical Devices
Official FDA - device recalls, safety, approvals, radiation-emitting products. Contact us DICE@fda.hhs.gov or 800-638-2041
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FDA Medical Devices retweeted
FDAWomen 7h
Make your next vacation a healthy one with these 5 tips:
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FDA Medical Devices 5h
Replying to @FDADeviceInfo
For more information on complying with UDI requirements, including providing required information to the Global Unique Device Identification Database (GUDID), visit our website.
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FDA Medical Devices 5h
The unique device identifier (UDI) for medical devices will ultimately improve patient safety, modernize post-market surveillance, and facilitate innovation. The FDA issued the first warning letter for UDI violations to help ensure compliance. Read more:
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FDA Medical Devices 5h
The is sharing the latest interim post-approval study results for Abiomed’s Impella RP System.
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FDA Medical Devices May 20
REMINDER: On May 21, 2019 from 3-4:30 p.m EST, the will host a webinar on the Unique Device Identification Convenience Kits final guidance. Registration is not necessary. Find out more about the upcoming webinar:
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FDA Medical Devices May 20
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FDA Medical Devices May 17
On May 16th, the identified a Class I Recall, the most serious type of recall: Ethicon recalls circular staplers for insufficient firing and failure to completely form staples. Find out more about the recall:
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FDA Medical Devices May 17
Replying to @US_FDA
Today, issued a Safety Communication, warning against the use of devices for diabetes management not authorized for sale in the US.
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FDA Medical Devices May 17
Patients and caregivers should be aware of diabetes management devices that have not been reviewed by the for use alone or along with other devices. Inaccurate glucose level readings or unsafe insulin dosing may result, which can lead to injury or death.
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FDA Medical Devices retweeted
FDAWomen May 14
This week we are celebrating National Women’s Health Week. Nearly 7 out of 10 U.S. women smokers want to stop smoking completely. Find resources designed for women to help you start being smoke-free today: via
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FDA Medical Devices retweeted
FDA_ORA May 15
During this offers tips to keep women safe when taking including vitamins, minerals, herbs & amino acids. LEARN MORE:
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FDA Medical Devices retweeted
U.S. FDA May 16
SAFETY ALERT: FDA is advising consumers, tattoo artists & retailers to avoid using/selling 6 recalled tattoo inks contaminated w/ bacteria that can cause infections & lead to serious health injuries when injected into the skin during a tattooing procedure.
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FDA Medical Devices May 15
Today, the shared an update on medical device reports and ongoing manufacturer’s postmarket surveillance study for . Find out more:
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FDA Medical Devices May 15
Replying to @US_FDA
As the celebrates National Women’s Health Week, we want to remind women that thermography should not be used in place of mammography to detect, diagnose, or screen for breast cancer. Find out more:
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FDA Medical Devices May 15
National Women’s Health Week serves as a reminder for women to make their health a priority and build positive health habits for life.
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FDA Medical Devices retweeted
FDAWomen May 14
Great heart health starts with prevention. Many women don’t know that heart disease is the leading cause of death for women. This National Women’s Health Week, spread the word and learn more about the risk factors:
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FDA Medical Devices May 10
Replying to @FDADeviceInfo
Deadlines: •5/10: Request to make a formal oral presentation at the panel meeting •5/20: Submit written comments to the panel •5/30: Attend the panel meeting in Gaithersburg, MD •6/24: Submit written comments on the proposed order to reclassify to docket FDA-2019-N-1250
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FDA Medical Devices May 10
Replying to @FDADeviceInfo
We are also seeking public input on the proposed reclassification of surgical staplers for internal use from Class I to Class II. We invite any interested parties to participate in the public panel meeting and to submit comments.
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FDA Medical Devices May 10
On May 30, 2019 the will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee from 9 a.m. to 4 p.m. EST in Gaithersburg, MD. **Note the time changed from 10 am as stated in the FR notice to 9 am**
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FDA Medical Devices retweeted
Medtech Insight May 4
Preferential Treatment: US FDA Asks Patients For Their Input
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