Data / Medical devices / Powered Insertion System For A Cochlear Implant Electrode Array
Powered Insertion System For A Cochlear Implant Electrode Array (QQH): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Powered Insertion System For A Cochlear Implant Electrode Array (product code QQH, Class 2, 21 CFR 874.4450). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on January 9, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QQH
- Device class
- 2
- Regulation
- 874.4450
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Costa Rica | 1 |
Makers of Powered Insertion System For A Cochlear Implant Electrode Array
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Iotamotion, Inc. | Vadnais Heights, MN, United States | Complaint file establishment, Manufacturer | 1 | October 1, 2021 | 0 | 1 | 0 | api.fda.gov |
| Nextern | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextern Costa Rica Ltd. | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.