Data / Medical devices / Strap, Head, Gas Mask / United States
FDA-registered makers of Strap, Head, Gas Mask in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Strap, Head, Gas Mask (product code BTK). 0 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
- Strap, Head, Gas Mask
- Product code
- BTK
- Country
- United States
Makers of Strap, Head, Gas Mask in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Allied Medical LLC | Earth City, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Customfab, Inc. | Anaheim, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Inc. | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marpac, Inc. | Albuquerque, NM, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metromed,inc | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepper Medical, Inc. | West Chester, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Somerset, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Small Beginnings Inc. | Hesperia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermedia Corporation | Shelton, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 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.