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DigniCap® Delta
Dignitana AB · Model 700-1005 · UDI-DI 00850036106296
PMC
Prescription
7
510(k) clearances
58
Adverse events (1 deaths)
1
Recalls
7
Facilities
Description
Power Cord EU, 16A/ 250V, C19, 3M
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-11-05 | Dignitana, Inc. | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated |
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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.