Data / Medical devices / United States / Microsonic, Inc.
Microsonic, Inc.: FDA-registered device maker in Ambridge, PA, United States, 1 510(k) clearance
Microsonic, Inc. is registered with the FDA (registration 2523819) in Ambridge, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 21, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2523819
- Address
- 2960 Duss Ave., Ambridge, PA, United States, 15003
- Owner or operator
- Microsonic, Inc. (2523819)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- #12 Standard Tube, #13 Medium Tube, #13 Thick Tube, #13 Double Wall Tube, Acrylic with Vinylflex Canal, Acrylic with Synth-A-Flex Canal, Addition Supra Plus, AgileEars, Alerite Body with Silicone Canal, Dri-Tube Moisture-Free Tubes, Vibrant Color Tube, Gold Lock DW,, ER Plugs, LifePlugs and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Protector, Hearing (Insert) | EWD | U | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 21, 1995 | K950912 | MEGA-SIL A-B | ESD | Substantially Equivalent | Microsonic, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 21, 1995. 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.