Med-el Elektromedizinische Geraete, GmbH
INNSBRUCK Tirol, AT
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH appears in FDA device records in INNSBRUCK Tirol, AT. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Med-el Elektromedizinische Geraete, GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- MED-EL Elektromedizinische Gereate, Gmbhenforcement report, recall
510(k) clearance history
FDA records hold 6 510(k) clearances for Med-el Elektromedizinische Geraete, GmbH between 2018 and 2020. The busiest year on record is 2018, with 2. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | PFO | Substantially Equivalent | |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | PFO | Substantially Equivalent | |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) | PFO | Substantially Equivalent | |
| K183373 | Bonebridge | PFO | Substantially Equivalent | |
| DEN170009 | Bonebridge | PFO | Unknown | |
| K172460 | ADHEAR System | LXB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710014 | 3000249315 | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH | FUERSTENWEG 77A, INNSBRUCK Tirol 6020 AT | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PFOActive Implantable Bone Conduction Hearing System
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- KAEForceps, Ent
- JYJGauge, Measuring
- LXBHearing Aid, Bone Conduction
- MCMImplant, Cochlear
- MPVImplant, Hearing, Active, Middle Ear, Partially Implanted
- LRCInstrument, Ent Manual Surgical
- ETBProsthesis, Partial Ossicular Replacement
- ETAReplacement, Ossicular Prosthesis, Total
- MMOTray, Surgical, Ent
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2356-2024 | Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant | A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device. | Class II | Open, Classified | |
| Z-2138-2019 | 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 MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. | Class II | Terminated | |
| Z-2137-2019 | 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 SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. | Class II | Terminated | |
| Z-2136-2019 | 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; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. | Class II | Terminated | |
| Z-1395-2017 | 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. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit. | Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain