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Medical Device Recalls | FDA
https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
WEBYou can find the date that a firm initiated a recall in the text of the recall notice. Recalls. 2023 Medical Device Recalls; 2022 Medical Device Recalls; 2021 Medical Device...
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Recalls, Corrections and Removals (Devices) | FDA
https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
WEBMandatory Device Recalls - 21 CFR 810. Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7.
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2022 Medical Device Recalls | FDA
https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls
WEBSD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results. 03/16/22. Celltrion USA Recalls Certain Point of...
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Medical Device Recalls - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm
WEB4 days ago · This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the...
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2023 Medical Device Recalls | FDA - U.S. Food and Drug Administration
https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls
WEBOct 18, 2023 · Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA: 02/08/2023: Smiths Medical Recalls Certain...
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Federal Court Enters Consent Decree Against Philips Respironics
https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep
WEBApr 9, 2024 · Immediately following Philips’ recall, the FDA issued an alert notifying device users that problems reportedly associated with the PE-PUR foam breakdown could potentially result in serious ...
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What is a Medical Device Recall? | FDA
https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall
WEBFDA uses the term “recall” when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law....
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FDA Announces Recall of Heart Pumps Linked to Deaths and …
https://kffhealthnews.org/news/article/fda-recall-abbott-heart-pumps-heartmate-deaths-injuries/
WEB2 days ago · The earliest such report filed with the FDA dates to at least 2020, according to a KFF Health News review of the database. Monday’s alert is the second Class 1 recall of a HeartMate device this year. In January, Abbott issued an urgent “ correction letter ” to hospitals about a separate issue in which the HeartMate 3 unintentionally ...
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2021 Medical Device Recalls | FDA
https://fda.gov/medical-devices/medical-device-recalls/2021-medical-device-recalls
WEBAll Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination (Updated 09/28/2021) 09/10/21. Bio-Medical Equipment Service Co. Recalls ...
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FDA Recalls Heart Failure Devices Linked to Injuries and Deaths
https://www.usnews.com/news/health-news/articles/2024-04-17/fda-recalls-heart-failure-devices-linked-to-injuries-and-deaths
WEB1 day ago · WEDNESDAY, April 17, 2024 (HealthDay News) -- Two implanted heart devices used by patients in end-stage heart failure are now under a strict U.S. Food and Drug Administration recall, after being ...
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