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Surface Electrode, Single-Pack
Synapse Biomedical, Inc. · Model 22-0031 · UDI-DI 00852184003441
0
510(k) clearances
23
Adverse events (2 deaths)
2
Recalls
3
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-11 | Synapse Biomedical Inc | Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events i |
| 2022-05-31 | Synapse Biomedical Inc | Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate stor |
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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.