Data / Medical devices / United States / Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc.: FDA-registered device maker in Morgantown, WV, United States, 2 510(k) clearances
Mylan Pharmaceuticals Inc. is registered with the FDA (registration 1110315) in Morgantown, WV, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1110315
- Address
- 3711 Collins Ferry Road, Morgantown, WV, United States, 26505
- Owner or operator
- Mylan Pharmaceuticals Inc. (10047905)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 9, 2017
- Registered through
- 2026
- Brand names listed
- Sodium Chloride 3% and 10%, Whisperject
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 12, 2014 | K141384 | WHISPERJECT AUTOINJECTOR | KZH | Substantially Equivalent | Scandinavian Health Limited | accessdata.fda.gov |
| October 8, 1997 | K972778 | DEY VIAL SODIUM CHLORIDE 3% | CAF | Substantially Equivalent | Dey Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2014. 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.