Data / Medical devices / Device, Inflation, Middle Ear
Device, Inflation, Middle Ear (MJV): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Device, Inflation, Middle Ear (product code MJV, Class U). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on February 10, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MJV
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| Sweden | 1 |
| Taiwan | 1 |
Makers of Device, Inflation, Middle Ear
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 |
|---|---|---|---|---|---|---|---|---|
| Circius Pharma AB | Askim Vastra Gotaland, Sweden | Manufacturer | 1 | October 5, 1992 | 0 | 0 | 0 | api.fda.gov |
| Earflo Company | Pittsburgh, PA, United States | Manufacturer, Specification developer | 1 | February 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Neilmed Pharmaceuticals, Inc. | Santa Rosa, CA, United States | Manufacturer | 1 | February 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Albert Novosino Co., Ltd. | Yuyao Zhejiang, China | Exporter to the US, Manufacturer | 1 | June 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Summit Medical LLC | Saint Paul, MN, United States | Contract manufacturer, Manufacturer | 1 | March 14, 2008 | 0 | 0 | 0 | api.fda.gov |
| Asia Connection Co., Ltd. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Entech Electronics Trade (shenzhen) Company Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 10, 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.