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Ophthalmic Speculum
AURORA SURGICAL, LLC · Model AS1-080 · UDI-DI 08175700100571
10
510(k) clearances
21
Adverse events
1
Recalls
190
Facilities
Description
Nevyas Drape Speculum, Open Wire, 16mm blades; designed to retain surgical drape under the eyelids
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
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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.