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Data / Medical devices / Catheters, Suction, Tracheobronchial

Catheters, Suction, Tracheobronchial (BSY): 174 FDA-registered makers in 20 countries

174 establishments in 20 countries are registered with the FDA to make Catheters, Suction, Tracheobronchial (product code BSY, Class 1, 21 CFR 868.6810). 11 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 116 510(k) clearances under this code, the latest on November 25, 2003, and lists 23 recall events (5 Class I). FDA data exported November 3, 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
BSY
Device class
1
Regulation
868.6810
Medical specialty
Anesthesiology

Makers by country

CountryMakers
China83
United States35
Mexico11
India9
Pakistan7
Taiwan7
United Kingdom4
France2
Italy2
Canada2
Germany2
Malaysia2
Belgium1
Colombia1
Belarus1
Hungary1
Turkey1
South Korea1
Japan1
Sweden1

Makers of Catheters, Suction, Tracheobronchial

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
Vygon S AECOUEN 95440 Val-d'Oise, FranceManufacturer, Specification developer3May 20, 1991000api.fda.gov
DimequipFrameries Hainaut, BelgiumManufacturer2May 20, 1991000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer1November 25, 2003000api.fda.gov
Em Innovations, Inc.Galloway, OH, United StatesSpecification developer1July 14, 1988000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1July 12, 1990000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer1July 12, 1990000api.fda.gov
Mallinckrodt Dar S.r.l.MIRANDOLA Modena, ItalyManufacturer1November 25, 2003000api.fda.gov
Neotech Products, LLCValencia, CA, United StatesManufacturer, Repackager or relabeler, Specification developer1June 19, 1986000api.fda.gov
Nurse Assist, LLCHaltom City, TX, United StatesManufacturer1February 12, 1985000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1June 1, 1989000api.fda.gov
Vygon Colombia S.A.BARRANQUILLA Atlantico, ColombiaContract manufacturer, Contract sterilizer, Manufacturer1May 20, 1991000api.fda.gov
Amarigo IncLos Angeles, CA, United StatesManufacturer0000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Amsino Medical (shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Angiplast Pvt. Ltd.Kheda Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Aoj Health Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ashtel Studios, Inc.Ontario, CA, United StatesSpecification developer0000api.fda.gov
Asomedica Co. LtdSmolevichi District Minsk, BelarusManufacturer0000api.fda.gov
Attract KFT.Pecsvarad Baranya, HungaryManufacturer0000api.fda.gov
AVENT S. de R.L. de C.V.NOGALES Sonora, MexicoManufacturer0000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesSpecification developer0000api.fda.gov
Aptyx - TrentonTRENTON Ontario, CanadaContract manufacturer0000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer0092api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Bicakcilar Tibbi Cihazlar Sanayi Ve Ticaret A.S.ESENYURT Istanbul, TurkeyManufacturer0000api.fda.gov
BLS Systems, Ltd.OAKVILLE Ontario, CanadaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Bioteque Corporation I-Lan Factory IISu-Ao Cheng Yilan, TaiwanContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0010api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Chinamed Products (china) Ltd.Gaoyao District Guangdong, ChinaManufacturer0000api.fda.gov
CHS USA IncorporatedPeachtree City, GA, United StatesSpecification developer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
CMC Manufacturing LLC Dba CMC Med SolutionsSanford, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Create Biotech Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Chongqing Sonmol Technology Co., Ltd.Chongqing, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer0000api.fda.gov
Dechoker LLCWheat Ridge, CO, United StatesManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Hong De Medical Plastic Products Co. Ltd.Dongguan Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Dragon Medical Co.,LtdSuzhou City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Evereast Medical Products Group Co., LtdChangyuan City Henan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Essentia Industries Ltd.Dong Guan Guangdong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.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
Fortune Medical Instrument Corp.Taoyuan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
FridaBaby LLCMiami, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Gbuk Group LimitedSelby North Yorkshire, United KingdomExporter to the US, Specification developer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guangdong Ecan Medical Co,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.Guangzhou 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, ChinaManufacturer0000api.fda.gov
Guangzhou Berrcom Medical Device Co., LtdGuangzhou Guangdong, ChinaManufacturer, Specification developer0000api.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
Headstar Medical Products Co., LtdNew Taipei City, TaiwanManufacturer0000api.fda.gov
Hitec Medical Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hospitech Manufacturing Services Sdn BhdShah Alam Selangor, MalaysiaManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Primecare Medical Co.,Ltd.hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Harsoria Healthcare Pvt. Ltd. (Unit-2)Baddi Himachal Pradesh, IndiaManufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Hynaut Health Technology Co., LTD.Qingdao Shandong, ChinaManufacturer0000api.fda.gov
Industrias Plasticas Medicas, S.A. De C.V.Ayala Morelos, MexicoManufacturer0000api.fda.gov
Innaccel Technologies Private LimitedBANGALORE Karnataka, IndiaManufacturer, Specification developer0000api.fda.gov
Insung Medical Co., Ltd.WONJU-SI Gangwon, South KoreaManufacturer0000api.fda.gov
Intersurgical Ltd.Wokingham, Berkshire, United KingdomComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Jiangmen Zhi Qu Metal Plastic Industrial Co., Ltd.Jiangmen, Guangdong, ChinaManufacturer0000api.fda.gov
Jiangsu Senwo Medical Technology Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangsu Suyun Medical Materials Co., Ltd.Lianyungang Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiangxi Glance Medical Equipment Co., Ltd.Nanchang City Jiangxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jinhua Kangdeli Medical Appliances Co.,ltdJinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
JWD. Technologies (jiangmen) Co.,ltd.Jiangmen Guangdong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Jiangxi Yiles Medical Co., LtdNanchang City Jiangxi, ChinaManufacturer0000api.fda.gov
Kindwell Medical Equipment Co., LtdJiangmen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Lian Xin Toys LtdDongGuan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Lianyungang Aoke Medical Equipment Co.,ltd.Lianyungang Jiangsu, ChinaManufacturer0000api.fda.gov
Madewell Medical Technology (malaysia) Sdn., Bhd.Kuala Ketil Kedah, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Mcreat ( Guangzhou ) Bio-Tech Co.,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0061api.fda.gov
Megasoft (china) Co.,ltd.Shishi Fujian, ChinaManufacturer0000api.fda.gov
NDH Medical, Inc.Saint Petersburg, FL, United StatesContract manufacturer0000api.fda.gov
Neo Dental Chemical Products Co., Ltd.Nagano, JapanManufacturer0000api.fda.gov
Ningbo Beierxin Baby Accessories Co., Ltd.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 Mflab Medical Instruments Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningbo Raffini Import & Export Co., LtdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningbo Xinwell Medical Technology Co., Ltd.Cixi Zhejiang, ChinaManufacturer0000api.fda.gov
NJR Medical, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
North American Rescue, LLC.Greer, SC, United StatesSpecification developer0000api.fda.gov
Novatech S.A.LA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer0000api.fda.gov
NeVap Inc Inventory ManagementSan Jose, CA, United StatesSpecification developer0000api.fda.gov
Ningbo Great Mountain Medical Instruments Co.,LtdNingbo Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Omnimate Enterprise Co., Ltd.Ilan County Yilan, TaiwanContract manufacturer0000api.fda.gov
Ouachita Contract Manufacturing, LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Pepper Medical, Inc.West Chester, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Plastics Plus Technology, Inc.Redlands, CA, United StatesContract manufacturer0000api.fda.gov
Poly Medicure LtdJaipur Rajasthan, IndiaManufacturer0000api.fda.gov
Polymed (xiamen) Plastic Industrial Co.,ltd.XIAMEN Fujian, ChinaContract manufacturer0000api.fda.gov
Productos Para El Cuidado De La SaludNOGALES Sonora, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
PROTOTAL Sweden ABJonkoping, SwedenManufacturer0000api.fda.gov
Pacific Hospital Supply Co., LtdTongluo Township Miaoli, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Primecare Medical (Suzhou) Co.,Ltd.Changshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Quick Aid LLCClearwater, FL, United StatesSpecification developer0000api.fda.gov
Quiroproductos de Cuauhtemoc S. De R.L. de C.V.Cuauhtemoc Chihuahua, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Romsons InternationalNOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Saferlife Products Co.,ltd.Guangzhou Guangdong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Sam Medical ProductsTualatin, OR, United StatesContract manufacturer0000api.fda.gov
Shaoxing Haitech Medical Products Co., LtdSHAOXING Zhejiang, ChinaManufacturer0000api.fda.gov
Shaoxing Jiancheng Medical Products Co., Ltd.Shaoxing 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 Bairunheng Technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Fitconn Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Insighters Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Oasis Innovations Technology Co.,ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen TPH Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Yimi Care Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Spencer Italia SRLSala Baganza Parma, ItalyManufacturer0000api.fda.gov
Spiracle TechnologyLos Alamitos, CA, United StatesSpecification developer0000api.fda.gov
Splash Medical Devices, LLCAtlanta, GA, United StatesSpecification developer0000api.fda.gov
Sscor, Inc.Simi Valley, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Stone Instruments Co.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Suru International Pvt LtdDAHANU Maharashtra, IndiaManufacturer0000api.fda.gov
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Sanbor Medical Xiamen, Inc.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Shijiazhuang Yide Medical Device Manufacturing Co., Ltd.Shijiazhuang City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
TKR Huanan Electronics (dongguan) Co., Ltd.Dongguan City Guangdong, ChinaManufacturer0000api.fda.gov
TMF Plastic Solutions LLCBradenton, FL, United StatesContract manufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Trinity Sterile, Inc.Salisbury, MD, United StatesManufacturer0000api.fda.gov
Tylenol Medical Instruments Co., Ltd.Zhongshan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Vitaltec CorporationHou Li District Taichung, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
VR Medical Technology Co., Ltd.KUNSHAN Jiangsu, ChinaManufacturer0000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Weldon InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Westmed de Mexico, S.A de C.VNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
Westmed de Mexico, S.A de C.VMAGDALENA Sonora, MexicoContract manufacturer0000api.fda.gov
Yadu Medical (henan) Co., LtdChangyuan Henan, ChinaManufacturer0000api.fda.gov
Yiwu Daqida Plastic Products Co., Ltd.Yiwu Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Baite Medical Appliances Co., Ltd.Huzhou City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Runqiang Medical Instruments Co.,ltd.Jiaxing Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zhuhai Ninuo Biological Technology Co.,ltdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
ZJG Royaltrust Med Co., Ltd.Zhangjiagang City Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Medtec Medical devices Co., LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhongshan Sunneo Medical Instruments Co.,LtdZhongshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated November 25, 2003. 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.