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Warning Letters | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
- Main FDA Warning Letter Page. Main FDA Warning Letter Page ... 11/17/2022: Mark S. Denker, M.D., PA dba Palm Beach Fertility Center ... CGMP/QSR/Medical …
2022 Safety Communications | FDA
- https://www.fda.gov/medical-devices/safety-communications/2022-safety-communications
- 09/06/2022. Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety …
2022 Medical Device Recalls | FDA - U.S. Food and …
- https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls
- 11/01/22. Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices. 10/18/22. Jiangsu …
Medical Device Safety | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/medical-device-safety
- This web section contains information about medical device safety issues. ...
2022 Device Approvals | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/recently-approved-devices/2022-device-approvals
- 2022 Device Approvals. The products listed in this section include some of the newest medical technology from the year 2022. The products in each list contain information …
Letters to Industry | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry
- A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act)." Consistent with …
Olympus Medical Systems Corporation - 649726
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corporation-649726-12122022
- Olympus Medical Systems Corporation MARCS-CMS 649726 — December 12, 2022. Olympus Medical Systems Corporation. Product: Medical Devices. Recipient: …
Letters to Health Care Providers | FDA
- https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers
- The FDA posts the letters it sends to health care providers about safety concerns with medical devices used in health care facilities.
2022 Year in Review: FDA Drug and Device Advertising …
- https://www.kslaw.com/news-and-insights/2022-year-in-review-fda-drug-and-device-advertising-and-promotion-enforcement
- Of the nine total advertising and promotion letters in 2022, four were issued by FDA’s Office of Prescription Drug Promotion (OPDP). Of these four, one was a …
FDA Warning Letter & Inspection …
- https://www.thefdagroup.com/blog/2019-fda-warning-letter-inspection-observation-trends
- In FY2022, FDA issued 24 warning letters related to medical devices. ( FDA data dashboard ) The number of Form 483s issued to medical device …
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