Data / Medical devices / Wire, Guide, Catheter
Wire, Guide, Catheter (DQX): 159 FDA-registered makers in 23 countries
159 establishments in 23 countries are registered with the FDA to make Wire, Guide, Catheter (product code DQX, Class 2, 21 CFR 870.1330). 108 of them have a 510(k) clearance or PMA approval on file and 15 have a recall event. The FDA has issued 769 510(k) clearances under this code, the latest on October 16, 2026, and lists 73 recall events (9 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
- DQX
- Device class
- 2
- Regulation
- 870.1330
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 87 |
| Japan | 11 |
| Mexico | 11 |
| Costa Rica | 9 |
| China | 7 |
| Ireland | 6 |
| Canada | 3 |
| Germany | 3 |
| Switzerland | 3 |
| Czechia | 2 |
| Denmark | 2 |
| Israel | 2 |
| Dominican Republic | 2 |
| Netherlands | 2 |
| Malaysia | 1 |
| Singapore | 1 |
| Taiwan | 1 |
| India | 1 |
| Thailand | 1 |
| Vietnam | 1 |
| France | 1 |
| Honduras | 1 |
| Philippines | 1 |
Makers of Wire, Guide, Catheter
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 |
|---|---|---|---|---|---|---|---|---|
| Asahi Intecc Co., Ltd. | SETO Aichi, Japan | Manufacturer, Specification developer | 49 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 42 | November 6, 2024 | 0 | 2 | 0 | api.fda.gov |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 34 | November 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 32 | December 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Manufacturer, Specification developer | 26 | September 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 26 | September 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 23 | September 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer, Manufacturer, Specification developer | 23 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 22 | January 31, 2026 | 0 | 3 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 20 | July 22, 2019 | 0 | 9 | 2 | api.fda.gov |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 16 | September 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 15 | October 11, 2023 | 0 | 1 | 0 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Contract manufacturer, Manufacturer | 14 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 12 | September 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Brivant, Ltd. | GALWAY Galway(County), Ireland | Complaint file establishment, Contract manufacturer, Manufacturer | 11 | March 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abbott Vascular | Barceloneta, PR, United States | Manufacturer | 9 | November 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Arrow International C.R. a.s. | ZDAR NAD SAZAVOU Vysocina, Czechia | Exporter to the US, Manufacturer, Repackager or relabeler | 9 | February 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Vascular Solutions LLC | Maple Grove, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 9 | May 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Filmecc Co., Ltd. | Seto-shi Aichi, Japan | Complaint file establishment, Manufacturer, Specification developer | 8 | September 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer | 8 | March 25, 2009 | 0 | 1 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 7 | March 1, 2004 | 0 | 9 | 0 | api.fda.gov |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 7 | March 13, 2006 | 0 | 3 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 7 | March 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Specification developer | 7 | July 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 6 | August 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Raynham, MA, United States | Manufacturer | 6 | August 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Heraeus Medical Components, LLC | Saint Paul, MN, United States | Complaint file establishment, Contract manufacturer, Specification developer | 6 | February 20, 2015 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 6 | July 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer | 6 | July 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| FMD. Co., Ltd. | Komaki Aichi, Japan | Manufacturer, Specification developer | 5 | June 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Opsens Inc. | Quebec City, Canada | Manufacturer | 5 | May 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Arrow International CR, a.s. | Hradec Kralove, Czechia | Exporter to the US, Manufacturer | 4 | August 15, 1993 | 0 | 0 | 0 | api.fda.gov |
| Arrow International LLC (subsidiary of Teleflex Incorporated) | Morrisville, NC, United States | Complaint file establishment, Specification developer | 4 | September 18, 2024 | 0 | 3 | 2 | api.fda.gov |
| Cook Medical LLC | Bloomington, IN, United States | Complaint file establishment, Contract manufacturer | 4 | November 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Repackager or relabeler, Specification developer | 4 | March 11, 2015 | 0 | 1 | 1 | api.fda.gov |
| Merit Medical Ireland, Ltd | Galway Galway(County), Ireland | Contract manufacturer, Repackager or relabeler | 4 | March 31, 1994 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Heart Valves Division | Santa Ana, CA, United States | Specification developer | 4 | June 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Specification developer | 4 | March 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | December 8, 2016 | 0 | 3 | 1 | api.fda.gov |
| Abbott Medical | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | October 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Saint Paul, MN, United States | Manufacturer, Specification developer | 3 | October 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Mississauga Ontario, Canada | Manufacturer, Specification developer | 3 | December 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Medical Device (Malaysia) SDN BHD | Taman Perindustrian Batu Kawan Pulau Pinang, Malaysia | Manufacturer | 3 | April 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Galt Medical Corp. | Garland, TX, United States | Contract manufacturer, Manufacturer | 3 | April 23, 2015 | 0 | 2 | 0 | api.fda.gov |
| Lake Region Medical Limited | NEW ROSS Wexford, Ireland | Contract manufacturer, Manufacturer | 3 | December 17, 2014 | 0 | 0 | 0 | api.fda.gov |
| Scientia Vascular | West Valley City, UT, United States | Manufacturer | 3 | July 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Salt Lake City, UT, United States | Manufacturer | 3 | March 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| Volcano Corporation | San Diego, CA, United States | Complaint file establishment, Specification developer | 3 | April 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Acme-Monaco Corp. | New Britain, CT, United States | Contract manufacturer, Manufacturer | 2 | July 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Allwell Medical Corporation | Raleigh, NC, United States | Manufacturer, Repackager or relabeler | 2 | March 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 2 | January 28, 1997 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 2 | November 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 2 | May 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| FMD Co., Ltd. Okinawa Factory | Uruma Okinawa, Japan | Contract manufacturer, Manufacturer | 2 | June 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Guidewire Technologies, Inc. | Salem, NH, United States | Contract manufacturer, Manufacturer | 2 | July 31, 1990 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer, Repackager or relabeler | 2 | December 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | February 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| Sunny Medical Device (shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | October 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Volcano Corporation | Rancho Cordova, CA, United States | Manufacturer | 2 | September 28, 2020 | 0 | 2 | 0 | api.fda.gov |
| Volcano Corporation by Volcarica S.R.L. | Coyol Alajuela, Costa Rica | Manufacturer | 2 | September 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| William Cook Europe Aps | BJAEVERSKOV Sjaelland, Denmark | Complaint file establishment, Manufacturer | 2 | November 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Minnetonka, MN, United States | Manufacturer | 1 | May 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Specification developer | 1 | May 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Acme-Monaco Corp. | Presque Isle, ME, United States | Contract manufacturer, Manufacturer | 1 | August 19, 1992 | 0 | 0 | 0 | api.fda.gov |
| Atricure, Inc. | Mason, OH, United States | Complaint file establishment, Manufacturer | 1 | August 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 1 | October 9, 1997 | 0 | 0 | 0 | api.fda.gov |
| Acme Monaco Asia Pte. Ltd. | Singapore Central Singapore, Singapore | Contract manufacturer, Manufacturer | 1 | August 19, 1992 | 0 | 0 | 0 | api.fda.gov |
| AtriCure, Inc. | Pleasanton, CA, United States | Specification developer | 1 | August 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer, Repackager or relabeler | 1 | January 28, 1997 | 0 | 0 | 0 | api.fda.gov |
| Baylis Medical Technologies Inc. | Mississauga Ontario, Canada | Complaint file establishment, Manufacturer | 1 | March 7, 2002 | 0 | 0 | 0 | api.fda.gov |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing, China | Manufacturer | 1 | February 18, 2021 | 0 | 0 | 0 | api.fda.gov |
| BIOMERICS Advanced Catheter | Brooklyn Park, MN, United States | Contract manufacturer, Manufacturer | 1 | April 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biotronik Se & Co. KG | Berlin, Germany | Exporter to the US, Manufacturer | 1 | December 4, 2008 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Specification developer | 1 | November 8, 2012 | 0 | 11 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 1 | November 9, 2017 | 0 | 0 | 0 | api.fda.gov |
| C2Dx, Inc. | Schoolcraft, MI, United States | Complaint file establishment, Manufacturer | 1 | March 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cardio Flow, Inc. | Blaine, MN, United States | Specification developer | 1 | March 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Howell, MI, United States | Manufacturer | 1 | May 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Confluent Medical Technologies, Inc | Fremont, CA, United States | Specification developer | 1 | August 28, 2001 | 0 | 1 | 1 | api.fda.gov |
| Cordis de Mexico SA de CV | Ciudad Juarez, Chihuahua Mexico, Mexico | Manufacturer | 1 | March 11, 1996 | 0 | 0 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 1 | June 14, 1977 | 0 | 0 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 1 | June 14, 1977 | 0 | 0 | 0 | api.fda.gov |
| Embrace Medical Ltd. | Tel Aviv, Israel | Complaint file establishment, Specification developer | 1 | July 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Flat Medical Co., Ltd. | Taipei, Taiwan | Complaint file establishment, Manufacturer, Specification developer | 1 | September 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | December 14, 2007 | 0 | 0 | 0 | api.fda.gov |
| Insitu Technologies, Inc. | Saint Paul, MN, United States | Specification developer | 1 | June 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Lepu Medical Technology (beijing) Co., Ltd | Beijing, China | Manufacturer | 1 | January 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 1 | March 11, 2015 | 0 | 2 | 0 | api.fda.gov |
| Mermaid Medical A/S | Stenloese Hovedstaden, Denmark | Manufacturer | 1 | March 31, 1994 | 0 | 0 | 0 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 1 | June 14, 1977 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Santa Rosa, CA, United States | Specification developer | 1 | October 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Manufacturer | 1 | July 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mermaid Medical A/S (FL Site) | University Park, FL, United States | Complaint file establishment, Specification developer | 1 | March 31, 1994 | 0 | 0 | 0 | api.fda.gov |
| Nano4imaging GMBH | Duesseldorf North Rhine-Westphalia, Germany | Manufacturer | 1 | March 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nipro Medical Industries Ltd. | TATEBAYASHI-SHI Gunma, Japan | Manufacturer | 1 | July 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Phenox Limited | Galway Galway(County), Ireland | Manufacturer | 1 | October 9, 2019 | 0 | 0 | 0 | api.fda.gov |
| Procedure Products, Inc. | Vancouver, WA, United States | Manufacturer | 1 | December 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| Rapid-Medical Ltd | yokneam Northern, Israel | Complaint file establishment, Manufacturer | 1 | September 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Solo Pace Inc | Brooklyn Park, MN, United States | Specification developer | 1 | January 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spectranetics Corp. | Colorado Springs, CO, United States | Complaint file establishment, Specification developer | 1 | February 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Stereotaxis, Inc. | Saint Louis, MO, United States | Manufacturer | 1 | August 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Sureax Medical, Corporation | San Diego, CA, United States | Complaint file establishment, Repackager or relabeler, Reprocessor, Specification developer | 1 | October 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Toray Industries, Inc. | CHUO-KU Tokyo, Japan | Complaint file establishment, Specification developer | 1 | December 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| Toray Industries, Inc. Seta Plant | OTSU Shiga, Japan | Manufacturer | 1 | December 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 1 | May 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 1 | July 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Vygon MFG | Dover, NH, United States | Manufacturer | 1 | July 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer | 1 | December 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Advanced Lifesciences Pvt. Ltd. | New Delhi, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arbor Endovascular | San Jose, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Artiria Medical SA | Geneva Geneve, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asahi Intecc (thailand) Co., Ltd. | Amphur Muang Pathumthani Pathum Thani, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asahi Intecc Hanoi Co., Ltd. | Hanoi Ha Noi, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Westford, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | El Coyol Alajuela, Costa Rica | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Dominican Republic Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Balt Extrusion | MONTMORENCY Val-d'Oise, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Balt Usa, LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Cartago | Cartago, Costa Rica | 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 | |
| CEA Global Dominicana d.b.a. Nissha Medical Technologies | San Pedro de Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centerline Biomedical | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health Costa Rica, S.A. | -- Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardiva Medical, Inc. | Guaymas Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deepintec Scientific Co., Ltd | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epflex Feinwerktechnik GMBH | DETTINGEN/ERMS Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Line International Corporation | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heraeus Medical Components, SRL | Guadalupe Cartago, Costa Rica | 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 | |
| I-Tek Medical, Inc. | White Bear Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imperative Care Inc. | Campbell, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, United States | 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 | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mehow Innovative (huizhou) Ltd. | Huizhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NeedleTech Products, Inc. | N Attleboro, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nitinol Devices & Components Costa Rica, S. R. L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | Best Noord-Brabant, Netherlands | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Piolax Medical Devices, Inc. | Yokohama Kanagawa, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Piraeus Medical, Inc. | Maple Grove, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straub Medical AG | Wangs Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Zenith Vascular Scitech Limited | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | 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 | |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Yamaguchi Corporation | Yamaguchi-shi, Japan | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theragenics Costa Rica Limitada | El Coyol, Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Toyoflex Cebu Corporation | Lapu-Lapu Cebu(Province), Philippines | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venusa de Mexico S. de R.L de C.V | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yokowo Co., Ltd | Tomioka Gunma, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zurich Medical Inc | Plymouth, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 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.