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Esteem® Glasscock Stabilizers

Envoy Medical Corporation · Model 1730 · UDI-DI 10812282020235

OAF Prescription
0
510(k) clearances
287
Adverse events
2
Recalls
4
Facilities

Description

Glasscock Stabilizers, Qty 2

Recalls

DateFirmReason
2018-06-28Envoy Medical CorporationSterile 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
2013-01-09Envoy Medical CorporationEnvoy 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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Data 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.