Home › Device types › SAW
Fluorescence Imaging For Breast Cancer Detection
FDA product code SAW · Class 3 · Unknown
6
Registered devices
0
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
Lumicell Direct Visualization System (DVS) — Lumicell, Inc.Lumicell Direct Visualization System (DVS) — Lumicell, Inc.Lumicell Direct Visualization System (DVS) — Lumicell, Inc.Lumicell Direct Visualization System (DVS) — Lumicell, Inc.Lumicell Direct Visualization System (DVS) — Lumicell, Inc.Lumicell Direct Visualization System (DVS) — Lumicell, Inc.
Recent 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 retain |
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