FDA warning letters: Medical devices
This page lists public FDA records related to Medical devices. Inclusion does not mean a company is currently out of compliance. Topics are assigned by keyword matching on FDA's subject line.
15 letters in the current window. Last checked Oct 16, 2026.
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| Company | Letter date | FDA subject |
|---|---|---|
| Unilam Co., LTD | Sep 22, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| O.N. Diagnostics, LLC | Sep 1, 2026 | Medical Device Reporting/Misbranded |
| Advance-Esthetic LLC | Aug 25, 2026 | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Lion Street Medical, d/b/a Pensar Medical LLC | Aug 21, 2026 | Medical Device Reporting/Misbranded |
| Nipro Renal Solutions USA, Corporation | Jul 24, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| Koven Technologies, Inc. | Jul 21, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| Specialty Health Products CO, LLC | Jul 7, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| Nihon Kohden Digital Health Solutions, LLC | Jun 12, 2026 | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| AseptiKits, LLC | Jun 4, 2026 | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| BlephEx, LLC | Jun 3, 2026 | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Linemaster Switch Corporation | May 27, 2026 | CGMP/QSR/Drug/Medical Devices/Adulterated |
| ZIIP, Inc. | May 22, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| 3B Medical, Inc. dba Reach Health, Inc. | May 20, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| BMC Medical Co., Ltd. | May 20, 2026 | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Skytron, LLC | May 19, 2026 | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |