MED-EL Elektromedizinische Geräte GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “MED-EL Elektromedizinische Geräte GmbH” (first 2025, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 148 days. Since 2017 the median was 148 days, against 148 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 3 | 267 |
| 2026 | 3 | 29 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name MED-EL Elektromedizinische Geräte GmbH took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | 4 | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 2 | 2 |
Review panels
Most recent MED-EL Elektromedizinische Geräte GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | ETB | 2026-04-03 | 29 |
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | ETA | 2026-04-03 | 29 |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | ETB | 2026-04-03 | 29 |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | ETA | 2025-01-17 | 268 |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | ETB | 2025-01-17 | 266 |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | ETB | 2025-01-17 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named MED-EL Elektromedizinische Geräte GmbH.
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.
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 Geraete GmbH (5 510(k)s)
- Med-El Corp. (0 510(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 Elektromedizinische Geräte GmbH?
FDA lists 6 510(k) clearances under the applicant name “MED-EL Elektromedizinische Geräte GmbH” (first 2025, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by MED-EL Elektromedizinische Geräte GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name MED-EL Elektromedizinische Geräte GmbH is 148 days. Since 2017: 148 days, versus 148 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under MED-EL Elektromedizinische Geräte GmbH?
The most frequent FDA product codes under this applicant name are ETB (Prosthesis, Partial Ossicular Replacement, 4); ETA (Replacement, Ossicular Prosthesis, Total, 2).
Next steps
- See all 6 MED-EL Elektromedizinische Geräte GmbH clearances with predicates and recalls
- Run predicate analysis for product code ETB, MED-EL Elektromedizinische Geräte GmbH'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.