Fda Medical Website Letters

Letters to Health Care Providers | FDA

https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers

Medical Device Safety Letters to Health Care Providers Letters to Health Care Providers The most recent letters to health care providers are listed by year in the left navigation. …

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

Email Print Learn about the types of warning letters on FDA's website. Matters …

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

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

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 …

Certain Philips Respironics Masks for BiPAP, CPAP …

https://www.fda.gov/medical-devices/letters-health-care-providers/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect

Email: [email protected] Phone: 800-638-2041 or 301-796-7100 If you need any further information or support concerning this issue, please contact Philips …

Potential Risk of Exposure to Toxic Compounds When …

https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured

Please contact the Fresenius Medical Care Medical Information Office at [email protected] or 1-855-616-2309 with any questions or inquiries …

Warning Letters | FDA - U.S. Food and Drug Administration

https://cacmap.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 FDA and the letter recipient that may have changed the regulatory status of …

Forms | FDA - U.S. Food and Drug Administration

https://www.fda.gov/about-fda/reports-manuals-forms/forms

Forms | FDA Forms Depending on the browser you are using, you may need to download the form to enable field fillable functionality. Use the following instructions to download the …

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 - 649726 - 12/12/2022 | FDA WARNING LETTER Olympus Medical Systems Corporation MARCS-CMS 649726 — …

RightEye receives FDA warning that its product is a medical device

https://www.massdevice.com/righteye-fda-warning-medical-device/

An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. The agency wrote in a letter, dated Dec. …