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Nucleus
COCHLEAR LIMITED · Model Z322475 · UDI-DI 09321502024938
PGQ
Prescription
0
510(k) clearances
261
Adverse events
3
Recalls
11
Facilities
Description
Cochlear EAC200 Series WaxStop Wax Management System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-10-16 | MED-EL Elektromedizinische Gereate, Gmbh | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. |
| 2018-10-16 | MED-EL Elektromedizinische Gereate, Gmbh | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. |
| 2018-10-16 | MED-EL Elektromedizinische Gereate, Gmbh | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. |
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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.