Fda Warning Letters 2023 Medical Devices

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2023 Safety Communications | FDA

https://www.fda.gov/medical-devices/safety-communications/2023-safety-communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

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

Posted Date Letter Issue Date Company Name Issuing Office Subject …

FDA Issues Two Warning Letters to Leading …

https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-issues-two-warning-letters-leading-manufacturer-endoscopes

January 10, 2023. The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. The FDA’s Center for …

2023 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls

2022 Medical Device Recalls. Device Name. Date. Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing …

Devices Approved in 2023 | FDA

https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2023

This page lists all medical devices approved through the CDRH Premarket Approval process (PMA) in 2023. For access to the approval packages for PMA originals …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation, and one of its subsidiaries, Aizu Olympus Co, …

FDA Issues Warning Letter to RightEye, LLC For Misbranding …

https://www.lexology.com/library/detail.aspx?g=f981401f-8095-4290-92f7-c3abf8be6890

USA February 13 2023. On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter [1] to RightEye, LLC (RightEye), the …

FDA Issues Warning Letter to RightEye LLC

https://www.natlawreview.com/article/fda-issues-warning-letter-to-righteye-llc-misbranding-and-adulteration

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter [1] to RightEye, LLC (RightEye), the manufacturer of the …

FDA Issues Warning Letter to RightEye, LLC For …

https://www.martindale.com/legal-news/article_sheppard-mullin-richter-hampton-llp_2559766.htm

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter[1] to RightEye, LLC (RightEye), the manufacturer of the …

2023 Biological Device Application Approvals | FDA

https://cacmap.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-device-application-approvals

The applications are listed in order by date of approval / clearance in reverse chronological order. 2023 Biological Device Application Approvals. Tradename/Common …

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