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Data / Medical devices / Connector, Airway (Extension)

Connector, Airway (Extension) (BZA): 118 FDA-registered makers in 25 countries

118 establishments in 25 countries are registered with the FDA to make Connector, Airway (Extension) (product code BZA, Class 1, 21 CFR 868.5810). 4 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 94 510(k) clearances under this code, the latest on March 5, 2009, and lists 11 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
BZA
Device class
1
Regulation
868.5810
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States30
China19
Mexico13
Taiwan12
Germany7
Pakistan5
Japan5
United Kingdom4
Malaysia3
Italy2
Canada2
Costa Rica2
Turkey2
Finland1
New Zealand1
Sri Lanka1
Switzerland1
India1
Ireland1
Israel1
Brazil1
Hong Kong1
Thailand1
France1
Lithuania1

Makers of Connector, Airway (Extension)

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
Intersurgical Ltd.Wokingham, Berkshire, United KingdomSpecification developer2June 17, 1992000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer1August 22, 1994000api.fda.gov
Mallinckrodt Dar S.r.l.MIRANDOLA Modena, ItalyManufacturer1August 22, 1994000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer1June 27, 1979000api.fda.gov
Accutron, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
AOK Tooling LimitedShen Zhen Guangdong, ChinaManufacturer0000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandManufacturer, Specification developer0000api.fda.gov
Anesthesia Associates, Inc.San Marcos, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aptyx - TrentonTRENTON Ontario, CanadaContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0010api.fda.gov
Baldus Sedation GmbH & Co. KGBendorf Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Biomerics CartagoCartago, Costa RicaContract manufacturer, Manufacturer0000api.fda.gov
Chinamed Products (china) Ltd.Gaoyao District Guangdong, ChinaManufacturer0000api.fda.gov
Choice One Medical IncWindsor Ontario, CanadaManufacturer0000api.fda.gov
Create Biotech Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Danyang Xinya Valve Co., Ltd.Danyang Jiangsu, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Dongguan Junhai Medical Device Co., LtdDong Guang City Guangdong, ChinaContract manufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesManufacturer0000api.fda.gov
Doner Industries, Inc.Rogers, AR, United StatesSpecification developer0000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Dujo Logos Inc. DBA: MEDICOMP MEDICALPrinceton, MN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
E.T.T Secure LLCRoy, UT, United StatesManufacturer0000api.fda.gov
Enter Medical CorporationChiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Excellentcare Medical (Huizhou) Ltd.Huizhou Guangdong, ChinaManufacturer0000api.fda.gov
Fisher & Paykel Healthcare, Ltd.EAST TAMAKI Auckland, New ZealandComplaint file establishment, Manufacturer0000api.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
Foremount Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Flexicare Lanka (Pvt) LtdBandaragama Western, Sri LankaContract manufacturer0000api.fda.gov
Galemed Corp.WU-JIA Yilan, TaiwanContract sterilizer, Manufacturer0000api.fda.gov
GPE MedTech Systeme GmbHDassow Mecklenburg-Western Pomerania, GermanyContract manufacturer0000api.fda.gov
GaleMed (Xiamen) Co., Ltd.XIAMEN Fujian, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gloor Ltd.Burgdorf Bern, SwitzerlandContract manufacturer, Manufacturer0000api.fda.gov
Haiyan Kangyuan Medical Instrument Co.,ltd.JiaXing Zhejiang, ChinaManufacturer0000api.fda.gov
Headstar Medical Products Co., LtdNew Taipei City, TaiwanManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hospitech Manufacturing Services Sdn BhdShah Alam Selangor, MalaysiaManufacturer0000api.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
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.Tijuana, B.C. C.P. Baja California, MexicoManufacturer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer0000api.fda.gov
ICU Medical, Inc.Highland, IN, United StatesManufacturer0000api.fda.gov
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Intechrity IncIrvine, CA, United StatesContract manufacturer0000api.fda.gov
Intersurgical Medical Apparatus (changzhou) Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Intersurgical S.P.A.Mirandola (MO) Italy Modena, ItalyManufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer0000api.fda.gov
King Systems Corporation.Noblesville, IN, United StatesManufacturer, Repackager or relabeler0010api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medical Devices (pvt) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Medisize Ireland Ltd.LETTERKENNY Donegal, IrelandContract manufacturer0000api.fda.gov
Meditech Systems LimitedShaftesbury Dorset, United KingdomManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medsource Factory,inc.CHANGZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Monitored Therapeutics, Inc.Dublin, OH, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.Tire Izmir, TurkeyContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer0000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer0000api.fda.gov
NextPhase Medical Devices Mexico LLCTIJUANA Baja California, MexicoContract manufacturer0000api.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
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production CenterFukaya-Shi Saitama, JapanManufacturer0000api.fda.gov
Omnimate Enterprise Co., Ltd.Ilan County Yilan, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Oridion Medical 1987 Ltd.Jerusalem, IsraelSpecification developer0000api.fda.gov
Padco Holding Company, LLCNewbury, OH, United StatesContract manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Passy-Muir, Inc.Irvine, CA, United StatesManufacturer, Specification developer0000api.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
Polymed (xiamen) Plastic Industrial Co.,ltd.XIAMEN Fujian, ChinaContract manufacturer0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoManufacturer0000api.fda.gov
Philips Medical Systems LtdaVarginha Minas Gerais, BrazilSpecification developer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Polimeros Formula de Tecate S.A de C.VTecate Baja California, MexicoContract manufacturer0000api.fda.gov
Quasar Engineering Ltd.Kowloon, Hong KongContract manufacturer0000api.fda.gov
Qinhuangdao Kapunuomaite Medical Equipment S&T Co., Ltd.Qinhuangdao Hebei, ChinaManufacturer0000api.fda.gov
Quasar Medical (Thailand) Co., LtdChonburi Chon Buri, ThailandContract manufacturer0000api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.Nuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
S & Mohr America, S.A. DE C.V.ESTADO DE MEXICO Ciudad de Mexico, MexicoManufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shaoxing Reborn Medical Devices Co.,ltdShaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Shenzhen Insighters Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
SipvEcouen Ile-de-France, FranceManufacturer0000api.fda.gov
Sleepres, IncFremont, CA, United StatesSpecification developer0000api.fda.gov
Soleetech CorporationLujhou Taipei, TaiwanManufacturer0000api.fda.gov
Sontek Medical, LLCRochester, NH, United StatesSpecification developer0000api.fda.gov
Sun May Industrial Co., Ltd.Pan Chiao City Taipei, TaiwanContract manufacturer0000api.fda.gov
Suzhou Yuyue Medical Technology Co., LtdSuzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer0000api.fda.gov
Salter Labs de Mexico de S.A. de C.V.Chihuahua Mexico, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Shanghai Draeger Medical Instrument Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Suzhou Meccan Import and Export Corp.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Thermedia CorporationShelton, WA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tracoe Medical GMBHNIEDER-OLM Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Teleflex Medical Sdn. Bhd.KAMUNTING Perak, MalaysiaManufacturer0000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer0000api.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
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer0000api.fda.gov
VYGON Germany GmbHAACHEN North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Ventis Medical IncPrinceton, NJ, United StatesManufacturer0000api.fda.gov
Volcano Corporation by Volcarica S.R.L.Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0010api.fda.gov
Westmed Javid de Mexico, S.A. de C.V.NOGALES Sonora, MexicoManufacturer0000api.fda.gov
Westmed de Mexico, S.A de C.VNOGALES Sonora, MexicoManufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov

Updated March 5, 2009. 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.