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Lumicell Direct Visualization System (DVS)
Lumicell, Inc. · Model 810-00210 · UDI-DI 00860003252505
SAW
Prescription
0
510(k) clearances
0
Adverse events
1
Recalls
3
Facilities
Description
Sterile Cover
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-31 | Lumicell, Inc. | The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies 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.
