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OSUNG MND
OSUNG MND Co., Ltd. · Model SH2S · UDI-DI 08800075626257
8
510(k) clearances
39
Adverse events
1
Recalls
267
Facilities
Description
A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-05-09 | Biomet 3i, Inc. | The drill malfunctions while in use. The drill has been observed to become lodged in the handle. |
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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.