Data / Medical devices / Tube Tracheostomy And Tube Cuff / United States
FDA-registered makers of Tube Tracheostomy And Tube Cuff in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Tube Tracheostomy And Tube Cuff (product code JOH). 14 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.
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- Device
- Tube Tracheostomy And Tube Cuff
- Product code
- JOH
- Country
- United States
Makers of Tube Tracheostomy And Tube Cuff 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 | 16 | November 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 13 | December 29, 2025 | 0 | 7 | 4 | api.fda.gov |
| ICU Medical, Inc. | Highland, IN, United States | Manufacturer | 9 | September 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Southington, CT, United States | Manufacturer | 8 | February 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 5 | December 12, 2019 | 0 | 3 | 1 | api.fda.gov |
| Passy-Muir, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 5 | June 11, 1999 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 4 | March 28, 2003 | 0 | 2 | 1 | api.fda.gov |
| Boston Medical Products, Inc. | Shrewsbury, MA, United States | Manufacturer | 1 | December 22, 1995 | 0 | 0 | 0 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | July 7, 1993 | 0 | 1 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer | 1 | October 9, 2012 | 0 | 0 | 0 | api.fda.gov |
| Safeguard Us Operating, LLC | Huntersville, NC, United States | Repackager or relabeler, Specification developer | 1 | July 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shikani Medical LLC | Lutherville, MD, United States | Specification developer | 1 | June 25, 2010 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | November 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | October 23, 1998 | 0 | 0 | 0 | api.fda.gov |
| Goodwill Commercial Services | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, 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 |
Updated November 3, 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.