Data / Medical devices / Ventilator, Continuous, Facility Use / United States
FDA-registered makers of Ventilator, Continuous, Facility Use in the United States: 48 establishments
48 establishments in the United States are registered with the FDA to make Ventilator, Continuous, Facility Use (product code CBK). 32 have a 510(k) clearance or PMA approval on file and 12 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, Continuous, Facility Use
- Product code
- CBK
- Country
- United States
Makers of Ventilator, Continuous, Facility Use in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Covidien | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 15 | November 20, 2020 | 0 | 2 | 2 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | 14 | December 30, 2024 | 0 | 34 | 15 | api.fda.gov |
| Datex-Ohmeda, Inc. | Madison, WI, United States | Manufacturer, Specification developer | 11 | November 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 7 | December 13, 2024 | 0 | 3 | 1 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer, Repackager or relabeler | 6 | July 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zoll Medical Corporation | Wilmington, MA, United States | Manufacturer, Repackager or relabeler | 6 | December 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 5 | May 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Orangemed, LLC | Santa Ana, CA, United States | Manufacturer | 4 | March 1, 2024 | 0 | 1 | 0 | api.fda.gov |
| Resmed Corp | San Diego, CA, United States | Complaint file establishment, Manufacturer | 4 | April 26, 2018 | 0 | 1 | 0 | api.fda.gov |
| Airon Corporation | Melbourne, FL, United States | Manufacturer | 3 | October 11, 2012 | 0 | 0 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer | 2 | June 14, 1988 | 0 | 0 | 0 | api.fda.gov |
| Bio-Med Devices, Inc. | Guilford, CT, United States | Manufacturer | 2 | July 20, 2018 | 0 | 2 | 0 | api.fda.gov |
| Event Medical, Ltd. | Lake Forest, CA, United States | Manufacturer | 2 | December 18, 2012 | 0 | 2 | 1 | api.fda.gov |
| Sleepnet Corporation | Hampton, NH, United States | Manufacturer, Manufacturer for export | 2 | August 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Breas Medical, Inc. | N Billerica, MA, United States | Complaint file establishment, Specification developer | 1 | December 19, 2025 | 0 | 1 | 0 | api.fda.gov |
| Corvent Medical Inc. | Fargo, ND, United States | Manufacturer | 1 | November 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hans Rudolph, Inc. | Shawnee, KS, United States | Manufacturer | 1 | May 2, 2003 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | April 28, 1998 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer | 1 | September 17, 1999 | 0 | 0 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Complaint file establishment, Manufacturer | 1 | June 13, 1991 | 0 | 0 | 0 | api.fda.gov |
| Lung Assist Ii Inc | Boulder, CO, United States | Specification developer | 1 | May 28, 1980 | 0 | 0 | 0 | api.fda.gov |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 1 | August 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Origin Medical Devices Inc | Newport Beach, CA, United States | Specification developer | 1 | July 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Oricare Inc. | Quakertown, PA, United States | Specification developer | 1 | June 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Percussionaire Corp. | Sandpoint, ID, United States | Manufacturer | 1 | May 3, 1991 | 0 | 4 | 3 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Complaint file establishment, Specification developer | 1 | August 17, 2006 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | August 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Telesair, Inc. | Irvine, CA, United States | Manufacturer | 1 | May 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ventec Life Systems, Inc. | Woodinville, WA, United States | Manufacturer | 1 | April 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ventec Life Systems, Inc. | Bothell, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 7, 2017 | 0 | 5 | 3 | api.fda.gov |
| Ventis Medical Inc | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Specification developer | 1 | August 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Foam Corporation dba MT. OLIVE MFG | Mooresville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hamilton Medical, Inc. | Reno, NV, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Corp | Lithia Spgs, GA, United States | Contract 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 | |
| Sechrist Industries, Inc. | Anaheim, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Sanmina Corporation | Carrollton, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| TD Synnex | Groveport, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecme Corporation | Norcross, GA, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| TreyMed, Inc. | Sussex, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOLL Medical Corporation | Pawtucket, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOLL Medical Corporation | Deerfield, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOLL Palm Springs | Palm Springs, CA, United States | Manufacturer for export | 0 | 0 | 3 | 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.