Home › Device types › DQA
Oximeter
FDA product code DQA · Class 2 · Cardiovascular
9,621
Registered devices
13,819
Adverse events
128
Recalls
726
510(k) clearances
Devices with this code
R-RUI — Beijing Rongrui-Century Scie.&Tech. Co,. Ltd.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.APK — APK Technology Co.,Ltd.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.APK — APK Technology Co.,Ltd.APK — APK Technology Co.,Ltd.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.PULSOX-300 — MAXTEC, LLCUnimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.APK — APK Technology Co.,Ltd.Nellcor — Covidien LPmedline — Beijing Choice Electronic Technology Co., Ltd.Trilogy — Respironics, Inc.Garbin — Respironics, Inc.Medichoice — OWENS & MINOR DISTRIBUTION, INC.Unimed — Unimed Medical Supplies, Inc.APK — APK Technology Co.,Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-06-23 | Covidien | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, |
| 2024-09-27 | Accriva Diagnostics, Inc. | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen lev |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.