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OSSEOUS
EON MEDITECH PRIVATE LIMITED · Model E3131015 · UDI-DI 08904428723737
KAC
Prescription
4
510(k) clearances
14
Adverse events (2 deaths)
1
Recalls
35
Facilities
Description
Laryngectomy Button is a self-retaining holder for device in the intended for vocal and pulmonary rehabilitation after Laryngectomy. It can supply stomal support and help to keep the tracheostoma open.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-12-15 | Smiths Medical ASD, Inc. | The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm. |
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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.