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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
    Matters described in FDA warning letters may have been subject to subsequent interaction between ...

2023 Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls
    An official website of the United States government Here’s how you know U.S. Food and Drug Administration Search Menu Home Medical Devices Medical Device …

FDA Roundup: January 10, 2023 | FDA

    https://www.fda.gov/news-events/press-announcements/fda-roundup-january-10-2023
    Today, the FDA’s Center for Devices and Radiological Health (CDRH) issued a statement regarding two recently issued warning letters to a leading manufacturer of …

Letters to Industry | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry

    Devices Approved in 2023 | FDA

      https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2023
      Devices Approved in 2023 Devices Approved in 2023 Share Tweet Linkedin Email Print This page lists all medical devices approved through the CDRH Premarket …

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

      https://www.fda.gov/Medical-Devices
      FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …

    Recent Final Medical Device Guidance Documents | FDA

      https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents
      Jan 12, 2023

    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
      FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration Tuesday, February 14, 2023 On January 31, 2023, the U.S. Food and Drug …

    Buzzagogo, LLC - 639545 - 01/18/2023 | FDA

      https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/buzzagogo-llc-639545-01182023
      January 18, 2023 RE: # 639545 Dear Joyce Dales: This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your …



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