Data / Medical devices / Tube, Tracheostomy (W/Wo Connector) / United States
FDA-registered makers of Tube, Tracheostomy (W/Wo Connector) in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Tube, Tracheostomy (W/Wo Connector) (product code BTO). 14 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Tube, Tracheostomy (W/Wo Connector)
- Product code
- BTO
- Country
- United States
Makers of Tube, Tracheostomy (W/Wo Connector) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 11 | April 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 5 | February 27, 1995 | 0 | 2 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 3 | March 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Boston Medical Products, Inc. | Shrewsbury, MA, United States | Manufacturer | 2 | August 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Highland, IN, United States | Manufacturer | 2 | June 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | December 16, 1976 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | April 23, 2010 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | April 23, 2010 | 0 | 0 | 0 | api.fda.gov |
| E. Benson Hood Laboratories, Inc. | Pembroke, MA, United States | Manufacturer | 1 | June 28, 1988 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 1 | September 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Inc. | Indianapolis, IN, United States | Manufacturer | 1 | March 29, 1983 | 0 | 0 | 0 | api.fda.gov |
| Passy-Muir, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 1 | June 7, 1985 | 0 | 0 | 0 | api.fda.gov |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 1 | November 3, 1988 | 0 | 0 | 0 | api.fda.gov |
| BD Medical Development | Crown Point, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intechrity Inc | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical | Philadelphia, PA, United States | Contract 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.