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SleepRight
Splintek Inc. · Model Snore Aid · UDI-DI 00692121035513
10
510(k) clearances
2,783
Adverse events (1 deaths)
10
Recalls
108
Facilities
Description
SleepRight Snore Aid is intended for use by adult patients 18 years of age or older as an aid for the reduction of snoring.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-27 | Prismatik Dentalcraft, Inc. | Due to device not having FDA Clearance |
| 2025-10-09 | Myofunctional Research Company USA | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. |
| 2022-05-23 | Dental Choice Holding Llc | The device was marketed and sold in the US without FDA clearance. |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently place |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.