Data / Medical devices / Ventilator, Emergency, Manual (Resuscitator) / United States
FDA-registered makers of Ventilator, Emergency, Manual (Resuscitator) in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Ventilator, Emergency, Manual (Resuscitator) (product code BTM). 15 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 3, 2026.
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- Device
- Ventilator, Emergency, Manual (Resuscitator)
- Product code
- BTM
- Country
- United States
Makers of Ventilator, Emergency, Manual (Resuscitator) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 11 | October 15, 2008 | 0 | 7 | 3 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer, Specification developer | 9 | January 31, 2008 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Specification developer | 4 | February 7, 2003 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 3 | February 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 3 | October 31, 1997 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | February 21, 1997 | 0 | 1 | 1 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Specification developer | 2 | May 6, 1994 | 0 | 1 | 0 | api.fda.gov |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Manufacturer, Repackager or relabeler | 1 | December 23, 2005 | 0 | 0 | 0 | api.fda.gov |
| Compact Medical Inc. | Indianapolis, IN, United States | Complaint file establishment, Specification developer | 1 | April 25, 2025 | 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 | 1 | 1 | api.fda.gov |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer | 1 | June 13, 1997 | 0 | 1 | 0 | api.fda.gov |
| Intersurgical Inc. | Indianapolis, IN, United States | Specification developer | 1 | April 6, 1993 | 0 | 0 | 0 | api.fda.gov |
| Safebvm Corp | Boston, MA, United States | Complaint file establishment, Specification developer | 1 | August 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Spiracle Technology | Los Alamitos, CA, United States | Specification developer | 1 | February 6, 2004 | 0 | 0 | 0 | api.fda.gov |
| 316 Contract Manufacturing LLC | Indianapolis, IN, 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 |
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.