Data / Medical devices / Nebulizer (Direct Patient Interface) / United States
FDA-registered makers of Nebulizer (Direct Patient Interface) in the United States: 41 establishments
41 establishments in the United States are registered with the FDA to make Nebulizer (Direct Patient Interface) (product code CAF). 35 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- Nebulizer (Direct Patient Interface)
- Product code
- CAF
- Country
- United States
Makers of Nebulizer (Direct Patient Interface) 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, Specification developer | 31 | April 25, 2013 | 0 | 2 | 0 | api.fda.gov |
| Pari Respiratory Equipment, Inc. | Midlothian, VA, United States | Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | 16 | January 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 15 | January 4, 2024 | 0 | 1 | 1 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 10 | October 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 8 | March 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| Monaghan Medical Corp. | Plattsburgh, NY, United States | Manufacturer, Repackager or relabeler | 7 | August 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 7 | February 16, 2005 | 0 | 0 | 0 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer, Repackager or relabeler | 5 | November 10, 2009 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 5 | March 19, 1998 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer | 5 | February 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries - Arlington Heights | Arlington Heights, IL, United States | Manufacturer | 5 | January 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Thayer Medical Corportation | Tucson, AZ, United States | Manufacturer | 4 | September 29, 2011 | 0 | 2 | 0 | api.fda.gov |
| The Ritedose Corporation | Columbia, SC, United States | Contract manufacturer, Manufacturer | 4 | December 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer, Specification developer | 3 | September 15, 2005 | 0 | 0 | 0 | api.fda.gov |
| DeVilbiss Healthcare LLC. | Somerset, PA, United States | Manufacturer | 3 | June 28, 2002 | 0 | 0 | 0 | api.fda.gov |
| Medi Nuclear Corp., Inc. | Baldwin Park, CA, United States | Manufacturer | 3 | November 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| ClensTech Inc.dba ASEPT PAK INC. | Malone, NY, United States | Contract manufacturer, Manufacturer | 2 | March 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 2 | November 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Nephron SC, LLC. | West Columbia, SC, United States | Manufacturer | 2 | June 19, 2012 | 0 | 1 | 0 | api.fda.gov |
| Pharmacaribe LLC | Naples, FL, United States | Specification developer | 2 | March 13, 2013 | 0 | 1 | 0 | api.fda.gov |
| Radnostix | Idaho Falls, ID, United States | Specification developer | 2 | March 19, 1997 | 0 | 0 | 0 | api.fda.gov |
| Alc Enterprises Inc | Brooklyn, NY, United States | Specification developer | 1 | May 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Amsino Healthcare (USA) Inc. | Vernon Hills, IL, United States | Manufacturer | 1 | February 23, 1982 | 0 | 1 | 1 | api.fda.gov |
| B & B Medical Technologies, Inc. | Carlsbad, CA, United States | Specification developer | 1 | May 27, 1998 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer | 1 | October 6, 1987 | 0 | 0 | 0 | api.fda.gov |
| Cognita Labs LLC | Santa Ana, CA, United States | Complaint file establishment, Manufacturer | 1 | September 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 1 | September 7, 2004 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Contract manufacturer, Manufacturer | 1 | June 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Inc. | Indianapolis, IN, United States | Specification developer | 1 | January 28, 2010 | 0 | 0 | 0 | api.fda.gov |
| Mediusa Inc. | Los Angeles, CA, United States | Remanufacturer, Repackager or relabeler | 1 | December 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| Mirion Technologies (capintec), Inc | Florham Park, NJ, United States | Manufacturer | 1 | January 1, 1985 | 0 | 0 | 0 | api.fda.gov |
| Mylan Pharmaceuticals Inc. | Morgantown, WV, United States | Specification developer | 1 | October 8, 1997 | 0 | 0 | 0 | api.fda.gov |
| MicroVapor Devices, LLC | West Columbia, SC, United States | Manufacturer | 1 | January 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Summit Medical LLC | Saint Paul, MN, United States | Contract manufacturer, Manufacturer | 1 | October 7, 1991 | 0 | 0 | 0 | api.fda.gov |
| Vapotherm Inc. | Exeter, NH, United States | Specification developer | 1 | October 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Blue Echo Care | Portland, OR, United States | 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 | |
| Creation Technologies Wisconsin Inc. | Oak Creek, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dualams,inc. Dba Airkor(r) | Irving, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Medical Products, Inc. | Birmingham, AL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Amery, WI, 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.