Data / Medical devices / Ventilator, Emergency, Powered (Resuscitator) / United States
FDA-registered makers of Ventilator, Emergency, Powered (Resuscitator) in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Ventilator, Emergency, Powered (Resuscitator) (product code BTL). 13 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Ventilator, Emergency, Powered (Resuscitator)
- Product code
- BTL
- Country
- United States
Makers of Ventilator, Emergency, Powered (Resuscitator) 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 | Manufacturer | 17 | April 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 6 | September 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Vortran Medical Technology 1, Inc. | Sacramento, CA, United States | Manufacturer, Repackager or relabeler | 3 | February 11, 2021 | 0 | 1 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 2 | January 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 2 | October 17, 2014 | 0 | 3 | 2 | api.fda.gov |
| Airon Corporation | Melbourne, FL, United States | Manufacturer | 1 | June 20, 2008 | 0 | 0 | 0 | api.fda.gov |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Manufacturer | 1 | October 13, 1992 | 0 | 0 | 0 | api.fda.gov |
| Datex-Ohmeda, Inc. | Wauwatosa, WI, United States | Specification developer | 1 | April 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| Datex-Ohmeda, Inc. | Waukesha, WI, United States | Specification developer | 1 | April 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 1 | September 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer | 1 | August 17, 1999 | 0 | 1 | 0 | api.fda.gov |
| MDL Solutions Incorporated | Hamel, MN, United States | Manufacturer | 1 | July 15, 2002 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | November 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Axcesor LLC | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxygen Therapy Institute | Jacksonville, FL, United States | 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.