Company
MED-EL Elektromedizinische Gereate, Gmbh
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2024 | MED-EL Elektromedizinische Gereate, Gmbh Mi1250 SYNCHRONY 2, Item Numbers:
a) 39541, FLEXSOFT S-Vector;
b) 39545, FLEX28 S-Vector;
c) 39547, FLEX26 S-Vector;
Cochlear Implant Open, Classified |
MCM | None listed |
| Oct 16, 2018 | MED-EL Elektromedizinische Gereate, Gmbh MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible Terminated |
PGQ | None listed |
| Oct 16, 2018 | MED-EL Elektromedizinische Gereate, Gmbh MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types:
a. SONATAti100 FLEXsoft;
b. SONATAti100 H Standard;
c. SONATAti100 Standard
Product Usage: The SONATATIi Terminated |
PGQ | None listed |
| Oct 16, 2018 | MED-EL Elektromedizinische Gereate, Gmbh MED EL Cochlear Implant System, Mi1000 MED EL
CONCERTO, sold under the following implant types:
a. Mil000 CONCERTO PIN +FLEX28;
b. Mi1000 CONCERTO +FLEX28;
c. Mi1000 CONCERTO PIN +FLEXsoft; Terminated |
PGQ | None listed |
| Mar 2, 2017 | MED-EL Elektromedizinische Gereate, Gmbh SONNET Mini Battery Pack CableProduct Usage:
The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. Terminated |
ISM | None listed |