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Distinguishing Medical Device Recalls from Medical …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/distinguishing-medical-device-recalls-medical-device-enhancements
- The key factor in distinguishing a medical device recall from an enhancement is the existence of a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 360h] or...
Medical Device Recalls | FDA
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
- The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that …
Distinguishing Medical Device Recalls from Medical …
- https://www.fda.gov/files/medical%20devices/published/Distinguishing-Medical-Device-Recalls-from-Medical-Device-Enhancements---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf
- FDA defines a device recall by regulation as a firm's removal or correction of a marketed device that the Agency considers to be in violation of the laws that it administers and …
2022 Medical Device Recalls | FDA
- https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls
- 2021 Medical Device Recalls Subscribe to Medical Device Safety and Recalls Sign up to receive email updates on medical device recalls, safety communications, and other safety …
2023 Medical Device Recalls | FDA
- https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls
- Feb 2, 2023
Medical Device Recalls - Food and Drug Administration
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm
- Feb 13, 2023
U.S. FDA classifies recall of Philips' respiratory devices as most ...
- https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-classifies-recall-philips-respiratory-devices-most-serious-2023-02-16/
- 1 day ago · Follow. Feb 16 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' (PHG.AS) …
U.S. FDA classifies recall of Philips' respiratory devices as most …
- https://finance.yahoo.com/news/u-fda-classifies-recall-philips-231246716.html
- 2 days ago · February 16, 2023, 6:12 PM · 1 min read. Feb 16 (Reuters) - U.S. health regulators on Thursday classified the recall of Dutch medical device maker Philips' …
GE HealthCare Recalls Nuclear Medicine Systems for …
- https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients
- 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 Medical Device …
FDA Guidance on Distinguishing Medical Device Recalls from …
- https://www.regdesk.co/fda-guidance-on-distinguishing-medical-device-recalls-from-enhancements-identifying-a-recall/
- As explained by the FDA, a recall could be initiated only concerning a medical device already placed on the market, while any changes made to the items …
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