Data / Medical devices / External Cleaning Solution / United States
FDA-registered makers of External Cleaning Solution in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make External Cleaning Solution (product code PME). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- External Cleaning Solution
- Product code
- PME
- Country
- United States
Makers of External Cleaning Solution in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bisco, Inc. | Schaumburg, IL, United States | Manufacturer | 1 | April 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Denali R & D Corporation | Hanover, MA, United States | Complaint file establishment, Specification developer | 1 | December 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| George Taub Products & Fusion Co., Inc. | Jersey City, NJ, United States | Manufacturer | 1 | December 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Inter-Med, Inc. | Racine, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Dental Manufacturing, Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viarden Lab LLC | Mission, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.