Home › Med-El Elektromedizinische Geräte Gesellschaft m.b.H. › SONNET 2 EAS Me1520 (AXIAL RCB) ebony
SONNET 2 EAS Me1520 (AXIAL RCB) ebony
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Model 37557 · UDI-DI 09008737375577
PGQ
Prescription
0
510(k) clearances
261
Adverse events
3
Recalls
11
Facilities
Description
Audio Processor
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.