Med-El Corp.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Med-El Corp.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCM | Implant, Cochlear | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000025 | PMA | COMBI 40+ COCHLEAR IMPLANT SYSTEM | 2001-08-20 |
Recalls
openFDA lists no recalls under a recalling firm named Med-El Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Med-El Corp. is the lead sponsor of 13 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07500311: Comparison of Performance Using MED-EL Automatic Sound Management (Enrolling by invitation, started 2026-04)
- NCT06734039: Impact of Anatomy-Based Cochlear Implant Programming on Early Performance (Enrolling by invitation, started 2025-11-10)
- NCT07028619: Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids (Completed, started 2025-06-26)
- NCT06597747: Design Improvements With SONNET 3 (Completed, started 2024-12-16)
- NCT05973669: MED-EL Remote Care Multi-Center Feasibility Study (Enrolling by invitation, started 2024-11-05)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Med-El Corp. (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via MCM)
- L8628 — Cochlear implant, external controller component, replacement (via MCM)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via MCM)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via MCM)
- L8627 — Cochlear implant, external speech processor, component, replacement (via MCM)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- MED-EL Elektromedizinische Geräte GmbH (6 510(k)s)
- Med-El Elektromedizinische Geraete GmbH (5 510(k)s)
- Med-El Elektromedizinische Gerate GmbH (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Med-El Corp.?
FDA lists 0 510(k) clearances under the applicant name “Med-El Corp.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Med-El Corp.?
The most frequent FDA product codes under this applicant name are MCM (Implant, Cochlear, 1).
Next steps
- See all 0 Med-El Corp. clearances with predicates and recalls
- Run predicate analysis for product code MCM, Med-El Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.