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Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA product code MNQ · Class 3 · Unknown
70
Registered devices
3,486
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Genio System 2.1 — NyxoahInspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Genio System 2.1 — NyxoahInspire — Inspire Medical Systems, Inc.Genio System 2.1 — NyxoahGenio System 2.1 — NyxoahInspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.Inspire — Inspire Medical Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-11 | Inspire Medical Systems Inc. | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a produ |
| 2026-05-11 | Inspire Medical Systems Inc. | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a produ |
| 2024-07-31 | Inspire Medical Systems Inc. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| 2024-07-31 | Inspire Medical Systems Inc. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| 2024-05-16 | Inspire Medical Systems Inc. | There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision |
| 2018-06-12 | Inspire Medical Systems Inc. | Incorrect use-by date on the device registration/patient file labels. |
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