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.
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
- KNT
- Device class
- 2
- Regulation
- 876.5980
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 79 |
| China | 20 |
| Mexico | 15 |
| United Kingdom | 4 |
| Ireland | 4 |
| Japan | 3 |
| France | 2 |
| Dominican Republic | 2 |
| Sweden | 2 |
| Malaysia | 2 |
| Poland | 2 |
| India | 2 |
| Israel | 1 |
| Belgium | 1 |
| Portugal | 1 |
| Germany | 1 |
| Denmark | 1 |
| Hungary | 1 |
| Canada | 1 |
| Costa Rica | 1 |
| Taiwan | 1 |
| Slovakia | 1 |
| Guatemala | 1 |
| Honduras | 1 |
| Thailand | 1 |
| Singapore | 1 |
| Latvia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 29 | October 25, 2024 | 0 | 11 | 2 | api.fda.gov |
| AVENT S. de R.L. de C.V. | NOGALES Sonora, Mexico | Manufacturer, Repackager or relabeler | 23 | October 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 22 | October 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 18 | October 29, 2020 | 0 | 5 | 0 | api.fda.gov |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 18 | October 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Avent S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 6 | July 21, 1997 | 0 | 0 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 6 | March 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Degania Silicone, Ltd. | DEGANIA BET Northern, Israel | Contract manufacturer, Manufacturer, Specification developer | 6 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer, Specification developer | 6 | October 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 5 | April 27, 2021 | 0 | 1 | 0 | api.fda.gov |
| Medtimo, Inc. | Eden Prairie, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | May 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Manufacturer, Specification developer | 5 | August 3, 2010 | 0 | 1 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 5 | October 31, 2022 | 0 | 1 | 0 | api.fda.gov |
| Actuated Medical, Inc. | Bellefonte, PA, United States | Manufacturer | 4 | December 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Convatec Dominican Republic, Inc. | Haina San Cristobal, Dominican Republic | Exporter to the US, Manufacturer | 4 | March 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Convatec Limited | Deeside Flintshire, United Kingdom | Manufacturer, Specification developer | 4 | April 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 4 | October 11, 2019 | 0 | 1 | 0 | api.fda.gov |
| Dimequip | Frameries Hainaut, Belgium | Manufacturer | 4 | March 23, 1998 | 0 | 0 | 0 | api.fda.gov |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 4 | August 18, 1995 | 0 | 1 | 0 | api.fda.gov |
| Moss Tubes, Inc. | Castleton on Hudson, NY, United States | Manufacturer, Specification developer | 4 | March 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| AbbVie Inc | North Chicago, IL, United States | Complaint file establishment, Specification developer | 3 | January 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| AbbVie US LLC | North Chicago, IL, United States | Manufacturer | 3 | January 14, 2015 | 0 | 2 | 0 | api.fda.gov |
| Boehringer Laboratories, LLC | Phoenixville, PA, United States | Manufacturer | 3 | May 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Multi-Med, Inc. | Keene, NH, United States | Contract manufacturer, Manufacturer | 3 | May 20, 2010 | 0 | 0 | 0 | api.fda.gov |
| Neochild, LLC | Oklahoma City, OK, United States | Specification developer | 3 | January 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer, Manufacturer for export | 2 | April 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 2 | April 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 2 | July 10, 2026 | 0 | 3 | 1 | api.fda.gov |
| CM Technologies, Inc. | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | November 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Codan Us Corp. | Santa Ana, CA, United States | Contract manufacturer, Manufacturer | 2 | March 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer, Specification developer | 2 | May 4, 2016 | 0 | 2 | 0 | api.fda.gov |
| Endolumik | Morgantown, WV, United States | Complaint file establishment, Specification developer | 2 | February 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| ENvue Medical (USA) Inc. | Arlington Heights, IL, United States | Specification developer | 2 | March 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Footprint Medical Inc. | San Antonio, TX, United States | Manufacturer | 2 | November 26, 2010 | 0 | 0 | 0 | api.fda.gov |
| Hollister Incorporated | Stuarts Draft, VA, United States | Manufacturer | 2 | October 13, 1993 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 2 | May 4, 2019 | 0 | 1 | 0 | api.fda.gov |
| Sipv | Ecouen Ile-de-France, France | Manufacturer | 2 | May 2, 1994 | 0 | 0 | 0 | api.fda.gov |
| Tools For Surgery, LLC | Stony Brook, NY, United States | Manufacturer | 2 | January 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 2 | October 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Vygon Portugal | Balter-Paredes Porto, Portugal | Manufacturer | 2 | May 2, 1994 | 0 | 0 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 2 | May 11, 2005 | 0 | 3 | 0 | api.fda.gov |
| Xeridiem Medical Devices | Tucson, AZ, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor | 2 | December 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| Advanced Medical Balloons GMBH | Waghaeusel Baden-Wurttemberg, Germany | Manufacturer | 1 | February 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer | 1 | January 12, 2000 | 0 | 0 | 0 | api.fda.gov |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 1 | June 27, 2008 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 1 | September 29, 2011 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson And Company | Columbus, NE, United States | Manufacturer | 1 | September 29, 2011 | 0 | 0 | 0 | api.fda.gov |
| Bionix, LLC | Maumee, OH, United States | Repackager or relabeler, Specification developer | 1 | February 13, 1991 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer, Manufacturer for export | 1 | June 27, 2003 | 0 | 3 | 0 | api.fda.gov |
| Becton, DIckinson and Company | Canaan, CT, United States | Manufacturer | 1 | September 29, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health 200, LLC | Jacksonville, TX, United States | Manufacturer | 1 | April 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Coloplast A/S | HUMLEBAEK Hovedstaden, Denmark | Specification developer | 1 | September 3, 2015 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Hungary KFT | NYIRBATOR Szabolcs-Szatmar-Bereg, Hungary | Manufacturer, Repackager or relabeler | 1 | September 3, 2015 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Manufacturer | 1 | April 28, 2006 | 0 | 0 | 0 | api.fda.gov |
| Cook Medical LLC | Bloomington, IN, United States | Complaint file establishment, Contract manufacturer | 1 | December 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| Canadian Hospital Specialties Ltd. | OAKVILLE Ontario, Canada | Manufacturer | 1 | June 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health Costa Rica, S.A. | -- Alajuela, Costa Rica | Manufacturer | 1 | June 12, 1985 | 0 | 0 | 0 | api.fda.gov |
| Changzhou CareU Medical Instruments Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 1 | December 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | April 28, 2006 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | May 11, 2005 | 0 | 0 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Contract manufacturer, Manufacturer | 1 | March 29, 1983 | 0 | 0 | 0 | api.fda.gov |
| Covidien llc | Santa Clara, CA, United States | Specification developer | 1 | September 28, 1994 | 0 | 0 | 0 | api.fda.gov |
| Dale Medical Products, Inc. | New London, CT, United States | Manufacturer | 1 | October 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Dynarex Corp. | Middletown, NY, United States | Specification developer | 1 | January 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Enteral Access Technologies, Ltd. | Caerwys Flintshire, United Kingdom | Manufacturer | 1 | September 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Fortune Medical Instrument Corp. | Taoyuan City, Taiwan | Contract manufacturer, Manufacturer | 1 | April 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| Gravitas Medical, Inc. | Berkeley, CA, United States | Complaint file establishment, Manufacturer | 1 | November 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Generica Medical International | La Verne, CA, United States | Complaint file establishment, Specification developer | 1 | July 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| Hospi Corporation | San Mateo, CA, United States | Specification developer | 1 | January 24, 2014 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Primecare Medical Co.,Ltd. | hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 1 | April 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| ICU MEDICAL DE MEXICO, S. de R.L. de C.V. | ENSENADA, Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | February 7, 1992 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Specification developer | 1 | February 7, 1992 | 0 | 0 | 0 | api.fda.gov |
| Kentec Medical, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | February 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Lake Region Medical | Chaska, MN, United States | Specification developer | 1 | September 28, 1994 | 0 | 0 | 0 | api.fda.gov |
| Maquet Critical Care AB | SOLNA Stockholm, Sweden | Manufacturer | 1 | December 11, 2015 | 0 | 0 | 0 | api.fda.gov |
| Marian Medical, Inc. | Barbourmeade, KY, United States | Manufacturer | 1 | January 28, 2005 | 0 | 0 | 0 | api.fda.gov |
| Medela LLC | Mchenry, IL, United States | Manufacturer | 1 | May 14, 2008 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 19, 2001 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Contract manufacturer, Manufacturer | 1 | March 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nexus Medical, LLC | Lenexa, KS, United States | Contract manufacturer, Specification developer | 1 | October 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Prosys International Ltd | London London, City of, United Kingdom | Exporter to the US, Specification developer | 1 | March 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Syncro Medical Innovations, Inc. | Macon, GA, United States | Specification developer | 1 | August 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| TeleMed Systems | Northborough, MA, United States | Specification developer | 1 | May 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Inc. | Cincinnati, OH, United States | Specification developer | 1 | October 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | June 18, 1986 | 0 | 0 | 0 | api.fda.gov |
| Vesco Medical LLC | New Albany, OH, United States | Specification developer | 1 | February 12, 2014 | 0 | 0 | 0 | api.fda.gov |
| VR Medical Technology Co., Ltd. | KUNSHAN Jiangsu, China | Manufacturer | 1 | February 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Contract sterilizer, Manufacturer | 1 | October 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Contract sterilizer, Manufacturer | 1 | October 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Wellspect Healthcare | Molndal Vastra Gotaland, Sweden | Manufacturer | 1 | November 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou Jiangsu, China | Specification developer | 1 | March 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| Zhangjiagang Shengang Medical Products Co.,ltd | Zhangjiagang Jiangsu, China | Exporter to the US, Manufacturer | 1 | January 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Acme-Monaco Corp. | New Britain, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Averto Medical | Redwood City, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| AbbVie Ireland NL B.V. Ballytivnan | Sligo, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - Charlotte | Charlotte, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Sdn. Bhd. | KULIM Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biometrix sro | Samorin Bratislavsky, Slovakia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Assembly, S. de R.L. de C.V. | Tijuana B.C. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CODAN US Corporation | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Shuyang Co., Ltd. | Shuyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinico Medical Sp. z o.o. | Blonie/Miekinia Dolnoslaskie, Poland | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coastline de Mexico SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degania Medical Devices Pvt. Ltd. | GURGAON Haryana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EPIC MedTec OEM LLC | Jaffrey, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexan (suzhou) Precision Rubber Products Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infus Medical Co., Ltd. | Khon Kaen Province, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Caina Medical Co., Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Shanghai) Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Singapore) Pte Ltd | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical Limited | NEW ROSS Wexford, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Outcomes Javid de Mexico | Nogales Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcreat ( Guangzhou ) Bio-Tech Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Tianyi Medical Appliance CO., Ltd. | Ningbo Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Padco Holding Company, LLC | Newbury, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parter Medical Products, Inc. | Carson, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRIDE Industries | Roseville, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Para El Cuidado De La Salud | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Putnam Medical Corp. | Dayville, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primecare Medical (Huzhou) Co.,Ltd. | Hu zhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QNQ Design and Development Pvt. Ltd. | New Delhi, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rockfield Medical Devices Ltd. | Galway Galway(County), Ireland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, S.A. | Santo Domingo Este, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SIA Elas Baltic | Jelgava, Latvia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Medical Poland SP. Z O.O. | Jelcz-Laskowice Dolnoslaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tessy Plastics Shanghai Co., Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tochigichizuka Plant | Chizuka, Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vesta | Franklin, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Laconia, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Virtex | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon MFG | Dover, NH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Xingwei Medical Technology Co., LTD | Yangzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.