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Data / Medical devices / Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase / United States

FDA-registered makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase in the United States: 59 establishments

59 establishments in the United States are registered with the FDA to make Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK). 32 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Product code
CCK
Country
United States

Makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer15November 12, 2024060api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler11June 10, 2025020api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer8August 19, 2003000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer5March 17, 2017000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer4December 14, 2016000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer, Repackager or relabeler3June 10, 2025000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer3March 21, 2013010api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer, Specification developer3December 14, 2016000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer2September 17, 2021031api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer2March 7, 2001000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer2March 29, 2021000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer, Repackager or relabeler2December 14, 2016000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer2January 12, 2006010api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2February 12, 2015000api.fda.gov
Aei Technologies Inc.Bastrop, TX, United StatesManufacturer1February 16, 1995000api.fda.gov
Affirm Medical Technologies Ii, LLCPiedmont, CA, United StatesComplaint file establishment, Specification developer1July 14, 2026000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer1November 24, 2014000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesManufacturer for export, Specification developer1June 4, 2025000api.fda.gov
CMI Health, Inc.Alpharetta, GA, United StatesSpecification developer1July 18, 2018000api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer1October 3, 1989000api.fda.gov
CareFusion 303, INCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 9, 2004000api.fda.gov
CareFusion 303, INC.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 9, 2004020api.fda.gov
Inventeur, LLCSaint Petersburg, FL, United StatesSpecification developer1December 16, 2024000api.fda.gov
Medipines CorporationYorba Linda, CA, United StatesManufacturer, Specification developer1January 11, 2019000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1January 22, 1993000api.fda.gov
Nasorcap Medical, Inc.Venetia, PA, United StatesManufacturer1August 14, 1992000api.fda.gov
Nonin Medical, Inc.Plymouth, MN, United StatesManufacturer1August 12, 1999000api.fda.gov
Pneuma Therapeutics, Inc.San Marcos, CA, United StatesSpecification developer1January 30, 2023000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer1December 13, 2005000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1April 19, 2018000api.fda.gov
Tri-Anim Health Services, Inc.Dublin, OH, United StatesSpecification developer1November 16, 2022000api.fda.gov
Vacumed, Div. Of Vacumetrics, Inc.Ventura, CA, United StatesManufacturer1May 26, 1998000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Axcesor LLCMenomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Breas Medical, Inc.N Billerica, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Flash GlobalLockbourne, OH, United StatesContract manufacturer0000api.fda.gov
Freespira, IncKirkland, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Specification developer0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Osi Optoelectronics (medical Division)Hawthorne, CA, United StatesContract manufacturer0000api.fda.gov
Oricare Inc.Quakertown, PA, United StatesSpecification developer0000api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
POM Medical, LLCMoorpark, CA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0020api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Salaera, LLC d.b.a MaxtecSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, 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.