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O2Vent Optima
OVENTUS MANUFACTURING PTY LTD · Model O2Vent Optima · UDI-DI 09351567000035
LRK
Prescription
1
510(k) clearances
2,783
Adverse events (1 deaths)
10
Recalls
108
Facilities
Description
The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
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.