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Mi1250 SYNCHRONY 2 FLEX24

Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Model 36680 · UDI-DI 09008737366803

PGQMCM Prescription
0
510(k) clearances
261
Adverse events
3
Recalls
11
Facilities

Description

Cochlear Implant

Recalls

DateFirmReason
2018-10-16MED-EL Elektromedizinische Gereate, GmbhDevices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
2018-10-16MED-EL Elektromedizinische Gereate, GmbhDevices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
2018-10-16MED-EL Elektromedizinische Gereate, GmbhDevices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

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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.