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Data / Medical devices / Tubes, Gastrointestinal (And Accessories)

Tubes, Gastrointestinal (And Accessories) (KNT): 152 FDA-registered makers in 27 countries

152 establishments in 27 countries are registered with the FDA to make Tubes, Gastrointestinal (And Accessories) (product code KNT, Class 2, 21 CFR 876.5980). 92 of them have a 510(k) clearance or PMA approval on file and 14 have a recall event. The FDA has issued 652 510(k) clearances under this code, the latest on September 30, 2026, and lists 54 recall events (4 Class I). FDA data exported November 2, 2026.

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Product code
KNT
Device class
2
Regulation
876.5980
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States79
China20
Mexico15
United Kingdom4
Ireland4
Japan3
France2
Dominican Republic2
Sweden2
Malaysia2
Poland2
India2
Israel1
Belgium1
Portugal1
Germany1
Denmark1
Hungary1
Canada1
Costa Rica1
Taiwan1
Slovakia1
Guatemala1
Honduras1
Thailand1
Singapore1
Latvia1

Makers of Tubes, Gastrointestinal (And Accessories)

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
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer29October 25, 20240112api.fda.gov
AVENT S. de R.L. de C.V.NOGALES Sonora, MexicoManufacturer, Repackager or relabeler23October 25, 2024000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer22October 23, 2018000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer18October 29, 2020050api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer18October 23, 2018000api.fda.gov
Avent S. de R.L. de C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler6July 21, 1997000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer6March 28, 2025000api.fda.gov
Degania Silicone, Ltd.DEGANIA BET Northern, IsraelContract manufacturer, Manufacturer, Specification developer6May 31, 2024000api.fda.gov
Vygon S AECOUEN 95440 Val-d'Oise, FranceManufacturer, Specification developer6October 29, 1999000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer5April 27, 2021010api.fda.gov
Medtimo, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Manufacturer, Specification developer5May 16, 2024000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesManufacturer, Specification developer5August 3, 2010010api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer5October 31, 2022010api.fda.gov
Actuated Medical, Inc.Bellefonte, PA, United StatesManufacturer4December 4, 2020000api.fda.gov
Convatec Dominican Republic, Inc.Haina San Cristobal, Dominican RepublicExporter to the US, Manufacturer4March 28, 2025000api.fda.gov
Convatec LimitedDeeside Flintshire, United KingdomManufacturer, Specification developer4April 30, 2019000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export4October 11, 2019010api.fda.gov
DimequipFrameries Hainaut, BelgiumManufacturer4March 23, 1998000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer4August 18, 1995010api.fda.gov
Moss Tubes, Inc.Castleton on Hudson, NY, United StatesManufacturer, Specification developer4March 22, 1999000api.fda.gov
AbbVie IncNorth Chicago, IL, United StatesComplaint file establishment, Specification developer3January 14, 2015000api.fda.gov
AbbVie US LLCNorth Chicago, IL, United StatesManufacturer3January 14, 2015020api.fda.gov
Boehringer Laboratories, LLCPhoenixville, PA, United StatesManufacturer3May 6, 2024000api.fda.gov
Multi-Med, Inc.Keene, NH, United StatesContract manufacturer, Manufacturer3May 20, 2010000api.fda.gov
Neochild, LLCOklahoma City, OK, United StatesSpecification developer3January 23, 2009000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer, Manufacturer for export2April 27, 2021000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer2April 27, 2021000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer2July 10, 2026031api.fda.gov
CM Technologies, Inc.Carrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer2November 17, 2021000api.fda.gov
Codan Us Corp.Santa Ana, CA, United StatesContract manufacturer, Manufacturer2March 19, 2012000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Specification developer2May 4, 2016020api.fda.gov
EndolumikMorgantown, WV, United StatesComplaint file establishment, Specification developer2February 8, 2024000api.fda.gov
ENvue Medical (USA) Inc.Arlington Heights, IL, United StatesSpecification developer2March 24, 2021000api.fda.gov
Footprint Medical Inc.San Antonio, TX, United StatesManufacturer2November 26, 2010000api.fda.gov
Hollister IncorporatedStuarts Draft, VA, United StatesManufacturer2October 13, 1993000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer2May 4, 2019010api.fda.gov
SipvEcouen Ile-de-France, FranceManufacturer2May 2, 1994000api.fda.gov
Tools For Surgery, LLCStony Brook, NY, United StatesManufacturer2January 10, 2025000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler2October 31, 2022000api.fda.gov
Vygon PortugalBalter-Paredes Porto, PortugalManufacturer2May 2, 1994000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer2May 11, 2005030api.fda.gov
Xeridiem Medical DevicesTucson, AZ, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor2December 19, 2013000api.fda.gov
Advanced Medical Balloons GMBHWaghaeusel Baden-Wurttemberg, GermanyManufacturer1February 9, 2023000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaContract manufacturer, Manufacturer1January 12, 2000000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler1June 27, 2008000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer1September 29, 2011000api.fda.gov
Becton Dickinson And CompanyColumbus, NE, United StatesManufacturer1September 29, 2011000api.fda.gov
Bionix, LLCMaumee, OH, United StatesRepackager or relabeler, Specification developer1February 13, 1991000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer, Manufacturer for export1June 27, 2003030api.fda.gov
Becton, DIckinson and CompanyCanaan, CT, United StatesManufacturer1September 29, 2011000api.fda.gov
Cardinal Health 200, LLCJacksonville, TX, United StatesManufacturer1April 9, 2014000api.fda.gov
Coloplast A/SHUMLEBAEK Hovedstaden, DenmarkSpecification developer1September 3, 2015000api.fda.gov
Coloplast Hungary KFTNYIRBATOR Szabolcs-Szatmar-Bereg, HungaryManufacturer, Repackager or relabeler1September 3, 2015000api.fda.gov
Conmed CorporationUtica, NY, United StatesManufacturer1April 28, 2006000api.fda.gov
Cook Medical LLCBloomington, IN, United StatesComplaint file establishment, Contract manufacturer1December 19, 2013000api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaManufacturer1June 3, 2014000api.fda.gov
Cardinal Health Costa Rica, S.A.-- Alajuela, Costa RicaManufacturer1June 12, 1985000api.fda.gov
Changzhou CareU Medical Instruments Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer1December 16, 2011000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1April 28, 2006000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer1May 11, 2005000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoContract manufacturer, Manufacturer1March 29, 1983000api.fda.gov
Covidien llcSanta Clara, CA, United StatesSpecification developer1September 28, 1994000api.fda.gov
Dale Medical Products, Inc.New London, CT, United StatesManufacturer1October 30, 2008000api.fda.gov
Dynarex Corp.Middletown, NY, United StatesSpecification developer1January 9, 2009000api.fda.gov
Enteral Access Technologies, Ltd.Caerwys Flintshire, United KingdomManufacturer1September 30, 2022000api.fda.gov
Fortune Medical Instrument Corp.Taoyuan City, TaiwanContract manufacturer, Manufacturer1April 3, 2003000api.fda.gov
Gravitas Medical, Inc.Berkeley, CA, United StatesComplaint file establishment, Manufacturer1November 22, 2024000api.fda.gov
Generica Medical InternationalLa Verne, CA, United StatesComplaint file establishment, Specification developer1July 28, 2014000api.fda.gov
Hospi CorporationSan Mateo, CA, United StatesSpecification developer1January 24, 2014000api.fda.gov
Hangzhou Primecare Medical Co.,Ltd.hangzhou Zhejiang, ChinaExporter to the US, Manufacturer1April 17, 2024000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler1February 7, 1992000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesSpecification developer1February 7, 1992000api.fda.gov
Kentec Medical, LLCIrvine, CA, United StatesComplaint file establishment, Specification developer1February 17, 2012000api.fda.gov
Lake Region MedicalChaska, MN, United StatesSpecification developer1September 28, 1994000api.fda.gov
Maquet Critical Care ABSOLNA Stockholm, SwedenManufacturer1December 11, 2015000api.fda.gov
Marian Medical, Inc.Barbourmeade, KY, United StatesManufacturer1January 28, 2005000api.fda.gov
Medela LLCMchenry, IL, United StatesManufacturer1May 14, 2008000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1October 19, 2001000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesContract manufacturer, Manufacturer1March 3, 2023000api.fda.gov
Nexus Medical, LLCLenexa, KS, United StatesContract manufacturer, Specification developer1October 23, 2009000api.fda.gov
Prosys International LtdLondon London, City of, United KingdomExporter to the US, Specification developer1March 13, 2020000api.fda.gov
Syncro Medical Innovations, Inc.Macon, GA, United StatesSpecification developer1August 9, 2016000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer1May 6, 2002000api.fda.gov
Teleflex Medical Inc.Cincinnati, OH, United StatesSpecification developer1October 31, 2022000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1June 18, 1986000api.fda.gov
Vesco Medical LLCNew Albany, OH, United StatesSpecification developer1February 12, 2014000api.fda.gov
VR Medical Technology Co., Ltd.KUNSHAN Jiangsu, ChinaManufacturer1February 17, 2012000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer, Contract sterilizer, Manufacturer1October 11, 2017000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer, Contract sterilizer, Manufacturer1October 11, 2017000api.fda.gov
Wellspect HealthcareMolndal Vastra Gotaland, SwedenManufacturer1November 22, 2019000api.fda.gov
Yangzhou Weideli Trading Co., Ltd.Yangzhou Jiangsu, ChinaSpecification developer1March 29, 2012000api.fda.gov
Zhangjiagang Shengang Medical Products Co.,ltdZhangjiagang Jiangsu, ChinaExporter to the US, Manufacturer1January 9, 2009000api.fda.gov
Acme-Monaco Corp.New Britain, CT, United StatesContract manufacturer0000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Averto MedicalRedwood City, CA, United StatesManufacturer for export0000api.fda.gov
AbbVie Ireland NL B.V. BallytivnanSligo, IrelandContract manufacturer0000api.fda.gov
Aptyx - CharlotteCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Bard Sdn. Bhd.KULIM Kedah, MalaysiaContract manufacturer0000api.fda.gov
Biometrix sroSamorin Bratislavsky, SlovakiaContract manufacturer0000api.fda.gov
Border Assembly, S. de R.L. de C.V.Tijuana B.C. Baja California, MexicoContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
CODAN US CorporationSan Diego, CA, United StatesContract manufacturer0000api.fda.gov
Conod Medical Shuyang Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Clinico Medical Sp. z o.o.Blonie/Miekinia Dolnoslaskie, PolandContract manufacturer, Contract sterilizer0000api.fda.gov
Coastline de Mexico SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Degania Medical Devices Pvt. Ltd.GURGAON Haryana, IndiaContract manufacturer0000api.fda.gov
EPIC MedTec OEM LLCJaffrey, NH, United StatesContract manufacturer0000api.fda.gov
Flexan (suzhou) Precision Rubber Products Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanSpecification developer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Infus Medical Co., Ltd.Khon Kaen Province, ThailandContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Jiangsu Caina Medical Co., LtdJiangyin Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jabil Circuit (Shanghai) Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Jabil Circuit (Singapore) Pte LtdSingapore Central Singapore, SingaporeContract manufacturer0000api.fda.gov
Jiangsu JianYu Health Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Lake Region Medical LimitedNEW ROSS Wexford, IrelandContract manufacturer0000api.fda.gov
Life Outcomes Javid de MexicoNogales Sonora, MexicoContract 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, ChinaContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Ningbo Tianyi Medical Appliance CO., Ltd.Ningbo Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Padco Holding Company, LLCNewbury, OH, United StatesContract manufacturer0000api.fda.gov
Parter Medical Products, Inc.Carson, CA, United StatesManufacturer for export0000api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
PRIDE IndustriesRoseville, CA, United StatesContract manufacturer0000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Productos Para El Cuidado De La SaludNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
Putnam Medical Corp.Dayville, CT, United StatesContract manufacturer0000api.fda.gov
Primecare Medical (Huzhou) Co.,Ltd.Hu zhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
QNQ Design and Development Pvt. Ltd.New Delhi, IndiaContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Rockfield Medical Devices Ltd.Galway Galway(County), IrelandComplaint file establishment, Specification developer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Remington Medical, S.A.Santo Domingo Este, Dominican RepublicContract manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
SIA Elas BalticJelgava, LatviaContract manufacturer0000api.fda.gov
Steripack Medical Poland SP. Z O.O.Jelcz-Laskowice Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Tessy Plastics Shanghai Co., LtdShanghai, ChinaContract manufacturer0000api.fda.gov
Tochigichizuka PlantChizuka, Tochigi, JapanContract manufacturer0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
VestaFranklin, WI, United StatesContract manufacturer0000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.fda.gov
VirtexAnoka, MN, United StatesContract manufacturer0000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer0010api.fda.gov
Westmed de Mexico, S.A de C.VNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
Yangzhou Xingwei Medical Technology Co., LTDYangzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov

Updated September 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.