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SourceMark
SOURCEMARK, LLC. · Model M1034 · UDI-DI 00813799006166
10
510(k) clearances
312
Adverse events (3 deaths)
2
Recalls
126
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-18 | Smiths Medical ASD Inc. | Uncertainty in the seal integrity of the sterile packaging. |
| 2017-01-13 | Teleflex Medical | Labeling error |
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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.