Nov 3, 2026
Center for Devices and Radiological Health
CGMP/QSR/Medical Devices/Adulterated
Next Medical Products Company, LLC
Warning letters
Device-related letters from the FDA.gov warning letter table: CDRH issuing office, or a device subject. Product code and class are not fields on the FDA letter listing.
12 records
Oct 27, 2026
Center for Devices and Radiological Health
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Pro-Optics, LLC
Oct 27, 2026
Center for Devices and Radiological Health
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Peter Schiff Enterprises
Oct 27, 2026
Center for Devices and Radiological Health
CGMP/QSR/Medical Devices/Adulterated
Chirp Innovations, LLC
Oct 20, 2026
Center for Biologics Evaluation and Research (C…
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Tides Medical LLC
Oct 20, 2026
Center for Devices and Radiological Health
CGMP/QSR/Medical Devices/Adulterated
Olympus Medical Systems Corporation
Oct 6, 2026
Center for Devices and Radiological Health
CGMP/QSR/Medical Devices/Adulterated
Unilam Co., LTD
Oct 6, 2026
Center for Devices and Radiological Health
Medical Device Reporting/Misbranded
O.N. Diagnostics, LLC
Sep 22, 2026
Center for Devices and Radiological Health
CGMP/QSR/Medical Devices/Adulterated
Specialty Health Products CO, LLC
Sep 22, 2026
Center for Devices and Radiological Health
Medical Device Reporting/Misbranded
Lion Street Medical, d/b/a Pensar Medical LLC
Sep 22, 2026
Center for Devices and Radiological Health
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Advance-Esthetic LLC
Aug 18, 2026
Center for Devices and Radiological Health
CGMP/QSR/Medical Devices/Adulterated
Nipro Renal Solutions USA, Corporation