Data / Medical devices / Apparatus, Vestibular Analysis
Apparatus, Vestibular Analysis (LXV): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Apparatus, Vestibular Analysis (product code LXV, Class U). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on April 27, 2022, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LXV
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Denmark | 2 |
| Ireland | 2 |
| Poland | 1 |
Makers of Apparatus, Vestibular Analysis
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 |
|---|---|---|---|---|---|---|---|---|
| Diversified Healthcare Development LLC. | Independence, VA, United States | Manufacturer | 2 | April 18, 2007 | 0 | 0 | 0 | api.fda.gov |
| Interacoustics A/S | Middelfart Syddanmark, Denmark | Complaint file establishment, Manufacturer, Specification developer | 2 | May 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| King-Devick Technologies, Inc | Oak Brook, IL, United States | Manufacturer | 1 | April 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sway Medical, Inc. | Tulsa, OK, United States | Manufacturer | 1 | September 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Ultrathera Technologies, Inc. | Colorado Springs, CO, United States | Manufacturer | 1 | April 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Upright Science, Inc. | Palm Bch Gdns, FL, United States | Manufacturer | 1 | August 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| DGS Diagnostics Sp. z o.o | Kolbaskowo Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Manufacturing Limited | GORT, Co. Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Medical Denmark ApS | TAASTRUP Hovedstaden, Denmark | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Sensory Ireland Ltd | Gort Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R and D Engineering Inc of Earlham | Earlham, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 27, 2022. 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.