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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer31April 25, 2013020api.fda.gov
Pari Respiratory Equipment, Inc.Midlothian, VA, United StatesManufacturer, Manufacturer for export, Repackager or relabeler, Specification developer16January 23, 2020000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer15January 4, 2024011api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer10October 25, 2011000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer8March 13, 2013000api.fda.gov
Monaghan Medical Corp.Plattsburgh, NY, United StatesManufacturer, Repackager or relabeler7August 24, 2023000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer7February 16, 2005000api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer, Repackager or relabeler5November 10, 2009000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer5March 19, 1998000api.fda.gov
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer5February 28, 2017000api.fda.gov
Medline Industries - Arlington HeightsArlington Heights, IL, United StatesManufacturer5January 4, 2024000api.fda.gov
Thayer Medical CorportationTucson, AZ, United StatesManufacturer4September 29, 2011020api.fda.gov
The Ritedose CorporationColumbia, SC, United StatesContract manufacturer, Manufacturer4December 3, 2021000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer, Specification developer3September 15, 2005000api.fda.gov
DeVilbiss Healthcare LLC.Somerset, PA, United StatesManufacturer3June 28, 2002000api.fda.gov
Medi Nuclear Corp., Inc.Baldwin Park, CA, United StatesManufacturer3November 26, 2008000api.fda.gov
ClensTech Inc.dba ASEPT PAK INC.Malone, NY, United StatesContract manufacturer, Manufacturer2March 13, 2013000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer2November 12, 1999000api.fda.gov
Nephron SC, LLC.West Columbia, SC, United StatesManufacturer2June 19, 2012010api.fda.gov
Pharmacaribe LLCNaples, FL, United StatesSpecification developer2March 13, 2013010api.fda.gov
RadnostixIdaho Falls, ID, United StatesSpecification developer2March 19, 1997000api.fda.gov
Alc Enterprises IncBrooklyn, NY, United StatesSpecification developer1May 30, 2014000api.fda.gov
Amsino Healthcare (USA) Inc.Vernon Hills, IL, United StatesManufacturer1February 23, 1982011api.fda.gov
B & B Medical Technologies, Inc.Carlsbad, CA, United StatesSpecification developer1May 27, 1998000api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer1October 6, 1987000api.fda.gov
Cognita Labs LLCSanta Ana, CA, United StatesComplaint file establishment, Manufacturer1September 13, 2019000api.fda.gov
CovidienCarlsbad, CA, United StatesComplaint file establishment, Specification developer1September 7, 2004000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesContract manufacturer, Manufacturer1June 18, 1998000api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesSpecification developer1January 28, 2010000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler1December 19, 2013000api.fda.gov
Mirion Technologies (capintec), IncFlorham Park, NJ, United StatesManufacturer1January 1, 1985000api.fda.gov
Mylan Pharmaceuticals Inc.Morgantown, WV, United StatesSpecification developer1October 8, 1997000api.fda.gov
MicroVapor Devices, LLCWest Columbia, SC, United StatesManufacturer1January 22, 2016000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesContract manufacturer, Manufacturer1October 7, 1991000api.fda.gov
Vapotherm Inc.Exeter, NH, United StatesSpecification developer1October 28, 2022000api.fda.gov
Blue Echo CarePortland, OR, United StatesManufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Creation Technologies Wisconsin Inc.Oak Creek, WI, United StatesContract manufacturer0000api.fda.gov
Dualams,inc. Dba Airkor(r)Irving, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nidek Medical Products, Inc.Birmingham, AL, United StatesManufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Amery, WI, United StatesContract manufacturer0000api.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.