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Eighteeth
Changzhou Sifary Medical Technology Co., Ltd. · Model ibT3040T · UDI-DI 06941877825188
4
510(k) clearances
10
Adverse events
3
Recalls
62
Facilities
Description
This device is a manual instrument and used in general surgery. It is intended for magnifying the surgical area for the surgeon during the operation. It is widely used in dentistry, ENT and other general surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2012-04-10 | Kerr Corporation | The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to speci |
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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.