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Data / Medical devices / Analyzer, Gas, Oxygen, Gaseous-Phase

Analyzer, Gas, Oxygen, Gaseous-Phase (CCL): 64 FDA-registered makers in 14 countries

64 establishments in 14 countries are registered with the FDA to make Analyzer, Gas, Oxygen, Gaseous-Phase (product code CCL, Class 2, 21 CFR 868.1720). 20 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 122 510(k) clearances under this code, the latest on July 30, 2026, and lists 5 recall events (0 Class I). 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.

Product code
CCL
Device class
2
Regulation
868.1720
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States29
China7
Germany6
Mexico4
Finland3
United Kingdom3
Japan3
Estonia2
India2
Singapore1
France1
Poland1
Malaysia1
Taiwan1

Makers of Analyzer, Gas, Oxygen, Gaseous-Phase

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Salaera, LLC d.b.a MaxtecSalt Lake City, UT, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler11April 1, 2023000api.fda.gov
Analytical Industries, Inc.Middleton, WI, United StatesManufacturer3April 5, 2006000api.fda.gov
Honeywell Healthcare Solutions GmbH (formerly EnviteC)WISMAR Mecklenburg-Western Pomerania, GermanyContract manufacturer, Manufacturer, Specification developer3January 23, 2013000api.fda.gov
Precision Medical, Inc.Northampton, PA, United StatesManufacturer2May 2, 2018000api.fda.gov
Aei Technologies Inc.Bastrop, TX, United StatesManufacturer1November 1, 1996000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandComplaint file establishment, Specification developer1July 30, 2026000api.fda.gov
Bio-Med Devices, Inc.Guilford, CT, United StatesManufacturer1March 17, 2022000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesManufacturer1November 3, 1999000api.fda.gov
DRW MedicalAston, PA, United StatesManufacturer1February 27, 2007000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Specification developer1May 25, 2005000api.fda.gov
It DR. Gambert GMBHWISMAR Mecklenburg-Western Pomerania, GermanyManufacturer1December 15, 2000000api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer1October 12, 1984000api.fda.gov
Life Spark MedicalHurricane, UT, United StatesManufacturer, Specification developer1April 24, 2025000api.fda.gov
Platinum Focus Group Ltd.London London, City of, United KingdomExporter to the US, Manufacturer1May 25, 2005000api.fda.gov
Salter LabsEl Paso, TX, United StatesManufacturer1July 30, 2026000api.fda.gov
Salter Labs de Mexico de S.A. de C.V.Chihuahua Mexico, MexicoManufacturer1March 17, 1999000api.fda.gov
Teledyne Analytical InstrumentsCity Industry, CA, United StatesManufacturer1June 30, 2000010api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1April 2, 1984010api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer1April 2, 1984000api.fda.gov
Vacumed, Div. Of Vacumetrics, Inc.Ventura, CA, United StatesManufacturer1May 26, 1998000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Airgas Therapeutics LLCPlumsteadville, PA, United StatesManufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Bluepoint Medical GMBH & Co. KGSelmsdorf Mecklenburg-Western Pomerania, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
City Technology LimitedPORTSMOUTH Hampshire, United KingdomContract manufacturer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.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
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
InosystemsANTONY Hauts-de-Seine, FranceContract manufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer0000api.fda.gov
Innokas Medical Estonia OuTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
KB Components Finland OyNurmijarvi Etela-Karjala, FinlandContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medipines CorporationYorba Linda, CA, United StatesManufacturer, Specification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Masimo Medical Technologies (Malaysia) SDN BHDPasir Gudang Johor, MalaysiaComplaint file establishment, Manufacturer0000api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer0000api.fda.gov
Noxbox LimitedSittingbourne Kent, United KingdomManufacturer0000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer0000api.fda.gov
Nihon Kohden Tomioka CorporationGunma Tokyo, JapanManufacturer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
RAUMEDIC Estonia ASTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Shenzhen Comen Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov

Updated July 30, 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.