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Data / Medical devices / Airway, Oropharyngeal, Anesthesiology

Airway, Oropharyngeal, Anesthesiology (CAE): 153 FDA-registered makers in 18 countries

153 establishments in 18 countries are registered with the FDA to make Airway, Oropharyngeal, Anesthesiology (product code CAE, Class 1, 21 CFR 868.5110). 3 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 57 510(k) clearances under this code, the latest on May 30, 2014, and lists 26 recall events (1 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
CAE
Device class
1
Regulation
868.5110
Medical specialty
Anesthesiology

Makers by country

CountryMakers
China69
United States31
Taiwan16
India8
Mexico5
Pakistan4
Malaysia4
United Kingdom4
Canada2
Germany2
Spain1
Vietnam1
Belarus1
Denmark1
Dominican Republic1
Italy1
Turkey1
Lithuania1

Makers of Airway, Oropharyngeal, Anesthesiology

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
Allied Medical LLCEarth City, MO, United StatesSpecification developer1April 9, 1986000api.fda.gov
King Systems Corporation.Noblesville, IN, United StatesRepackager or relabeler, Specification developer1April 14, 2004090api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1May 30, 2014010api.fda.gov
Airguard LLCFairfield, CT, United StatesSpecification developer0000api.fda.gov
Airway Innovations, Inc.Buffalo Grove, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ajl Ophthalmic, S.A.MINANO Alava, SpainManufacturer, Specification developer0000api.fda.gov
AMBU LimitedXIANG YU F.T.Z., XIAMEN Fujian, ChinaContract manufacturer0000api.fda.gov
An Lanh Investment And Trading Company LimitedThanh Nam Ward Ninh Binh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Arete Medical DevicesMullica Hill, NJ, United StatesManufacturer0000api.fda.gov
Asia Connection Co., Ltd.New Taipei City, TaiwanContract manufacturer, Exporter to the US0000api.fda.gov
Asomedica Co. LtdSmolevichi District Minsk, BelarusManufacturer0000api.fda.gov
Ambu A/SBallerup Hovedstaden, DenmarkSpecification developer0000api.fda.gov
Anesthesia Associates, Inc.San Marcos, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
BESMED HEALTH BUSINESS CORP.-ChiayiDalin Township Chiayi(County), TaiwanManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
BLS Systems, Ltd.OAKVILLE Ontario, CanadaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Bonree Medical Co., LtdZhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Besmed Health Business CorporationNew Taipei City, TaiwanManufacturer0010api.fda.gov
Bio-Med Healthcare Products Pvt. Ltd.Palwal Haryana, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Bo Cheng Technology Co., Ltd., Dongguan CityDongguan City Guangdong, ChinaManufacturer0000api.fda.gov
CCB Medical Devices Sdn BhdSIMPANG AMPAT Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Changsha Magill Medical Technology Co., Ltd.Changsha Hunan, ChinaManufacturer0000api.fda.gov
Create Biotech Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Changzhou Rongxin Medicine Minimal Invasion Technology Co., LtdJintan Jiangsu, ChinaManufacturer0000api.fda.gov
Coomex Sources Co. Ltd.Qingdao City Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer0000api.fda.gov
Danyang Xinya Valve Co., Ltd.Danyang Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dongyang City Yonoel Outdoor Products Co.,ltdDongyang Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Doner Industries, Inc.Rogers, AR, United StatesSpecification developer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Endure Industries, Inc.Homer, NY, United StatesManufacturer0000api.fda.gov
Evereast Medical Products Group Co., LtdChangyuan City Henan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Excellentcare Medical (Huizhou) Ltd.Huizhou Guangdong, ChinaManufacturer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer0000api.fda.gov
Forefront (xiamen) Medical Devices Co., Ltd.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Forefront Medical Technology (jiangsu) Co.,ltdChangzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Foremount Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Fortune Medical Instrument Corp.Taoyuan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Galemed Corp.WU-JIA Yilan, TaiwanManufacturer0000api.fda.gov
Gardner Medical Instruments, LLCFrankfort, IL, United StatesSpecification developer0000api.fda.gov
Gcmedica Enterprise Ltd. (wuxi)Wuxi Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guangdong Ecan Medical Co,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Amk Medical Equipment Co.,ltd.Guang zhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
GaleMed (Xiamen) Co., Ltd.XIAMEN Fujian, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Haiyan Kangyuan Medical Instrument Co.,ltd.JiaXing Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Formed Medical Devices Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Shanyou Medical Equipment Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Headstar Medical Products Co., LtdNew Taipei City, TaiwanManufacturer0000api.fda.gov
Henan Tuoren Medical Device Co., Ltd.Changyuan Henan, ChinaManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hitec Medical Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Fushan Medical Appliance Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Tappa Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Harsoria Healthcare Pvt. Ltd. (Unit-2)Baddi Himachal Pradesh, IndiaContract manufacturer, Contract sterilizer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
Integral Medical Products Co., Ltd.SHAOXING Zhejiang, ChinaContract manufacturer0000api.fda.gov
Intersurgical Ltd.Wokingham, Berkshire, United KingdomSpecification developer0000api.fda.gov
IPE Plastic & Hardware Industy, LTDDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Jescope Ltd.Taipei, TaiwanManufacturer0000api.fda.gov
Jiangxi Glance Medical Equipment Co., Ltd.Nanchang City Jiangxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jie Gao Medical Plastic Products (malaysia) Sdn. Bhd.Klang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Jie Gao Plastic Products Co., Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Jinhua Kangdeli Medical Appliances Co.,ltdJinhua Zhejiang, ChinaManufacturer0000api.fda.gov
Jiangxi Yiles Medical Co., LtdNanchang City Jiangxi, ChinaManufacturer0000api.fda.gov
Lamed Private LimitedFARIDABAD Haryana, IndiaManufacturer0000api.fda.gov
Made, University Of IowaIowa City, IA, United StatesManufacturer0000api.fda.gov
Mcmurray MedicalMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
Mcreat ( Guangzhou ) Bio-Tech Co.,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Meditech Systems LimitedShaftesbury Dorset, United KingdomManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0041api.fda.gov
Microtek Dominicana, S.A.S.La Romana, Dominican RepublicContract manufacturer0000api.fda.gov
Mallinckrodt Dar S.r.l.MIRANDOLA Modena, ItalyManufacturer0000api.fda.gov
MedSource Labs, LLCChanhassen, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer0000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Nasorcap Medical, Inc.Venetia, PA, United StatesManufacturer0000api.fda.gov
Ningbo Besmed Medical Equipment Corp.NINGBO Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Chibanda Imp &exp Co, LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Specification developer0000api.fda.gov
Ningbo Hanyue Medical Technology Co.,ltdCIXI CITY Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Huakun Medical Equipment Co.,ltdCixi Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Luke Medical Devices Co., Ltd.Yuyao Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Risenmed Technology Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Non-Change Enterprise Co., Ltd.New Taipei City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Ningbo Great Mountain Medical Instruments Co.,LtdNingbo Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
O-Two Medical Technologies, Inc.Brampton Ontario, CanadaManufacturer0000api.fda.gov
Oechsler Mexico S.A. De C.V.Santiago de Queretaro, MexicoContract manufacturer0000api.fda.gov
Omnimate Enterprise Co., Ltd.Ilan County Yilan, TaiwanContract manufacturer, Contract sterilizer, Manufacturer0000api.fda.gov
Ony Biotech Inc.Amherst, NY, United StatesManufacturer0000api.fda.gov
P3 Medical LtdBristol Bristol, City of, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.Tuzla Istanbul, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
Poly Medicure Ltd.Faridabad Haryana, IndiaManufacturer0000api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.Nuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Romsons InternationalNOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Rusun Medical Co., LtdYichun City Jiangxi, ChinaManufacturer0000api.fda.gov
Shandong Jinlai Huanhai Medical Technology Co.,ltdYantai Shandong, ChinaManufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shaoxing Haitech Medical Products Co., LtdSHAOXING Zhejiang, ChinaManufacturer0000api.fda.gov
Shaoxing Reborn Medical Devices Co.,ltdShaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Shaoxing Undis Medical Technology Company LimitedShaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Shenzhen Insighters Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Junyuan Medical Equipment Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Soleetech CorporationLujhou Taipei, TaiwanManufacturer0000api.fda.gov
Suru International Pvt LtdDAHANU Maharashtra, IndiaManufacturer0000api.fda.gov
Salter LabsEl Paso, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0010api.fda.gov
The Lethean Company, LLCChester Sprgs, PA, United StatesManufacturer0000api.fda.gov
Tianjin Medan Medical Corp.Tianjin, ChinaManufacturer0000api.fda.gov
Tianjin Medis Medical Device Co., Ltd.Tianjin, Tianjin, ChinaManufacturer, Specification developer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer0000api.fda.gov
Tender CorporationLittleton, NH, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
The Laryngeal Mask Company (M) SDN. BHD.Kulim Kedah, MalaysiaManufacturer, Specification developer0000api.fda.gov
Tylenol Medical Instruments Co., Ltd.Zhongshan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
UAB IntersurgicalPABRADE Svencionys, LithuaniaContract manufacturer0000api.fda.gov
VADI Medical Technology Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
VBM Medizintechnik GMBHSULZ AM NECKAR Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Vitaltec CorporationHou Li District Taichung, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Wilamed GMBHKammerstein Bavaria, GermanyContract manufacturer0000api.fda.gov
WM&DGNorthbrook, IL, United StatesManufacturer, Specification developer0000api.fda.gov
Westmed Javid de Mexico, S.A. de C.V.NOGALES Sonora, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Xi'an Haiye Medical Equipment Co,.ltd.Xi'an City Shaanxi, ChinaManufacturer0000api.fda.gov
Xiamen Compower Medical Tech. Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xponent Healthcare IncHudson, MA, United StatesManufacturer0000api.fda.gov
Xiamen Zhiyuan Medical Technology Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Yiwu Kebon Healthcare Co., Ltd.Yiwu Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaContract manufacturer, Contract sterilizer, Manufacturer0000api.fda.gov
Zhejiang Sungood Technology Co.,ltdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Hongze Medical Technology Co., Ltd.Zhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Zhejiang UE Medical Corp.Xianju Zhejiang, ChinaManufacturer0000api.fda.gov

Updated May 30, 2014. 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.