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MIRA IMEX Scleral Buckling Component
MIRA, INC. · Model 219 · UDI-DI 10850510007115
1
510(k) clearances
26
Adverse events
13
Recalls
13
Facilities
Description
Strip 4.5mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
| 2002-11-29 | Gulden Ophthalmics | lack of sterility assurance |
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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.