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Esteem® Ear Insert Assembly
Envoy Medical Corporation · Model 1200 · UDI-DI 00812282020344
OAF
Prescription
0
510(k) clearances
287
Adverse events
2
Recalls
4
Facilities
Description
Sterile Ear Insert Assembly, Small (9.7mm Foam)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-28 | Envoy Medical Corporation | Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior |
| 2013-01-09 | Envoy Medical Corporation | Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility |
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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.