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OSUNG MND
OSUNG MND Co., Ltd. · Model SNF20 · UDI-DI 08800075601643
10
510(k) clearances
9
Adverse events
1
Recalls
141
Facilities
Description
A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in |
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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.