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Data / Medical devices / Catheter, Intravascular, Diagnostic

Catheter, Intravascular, Diagnostic (DQO): 124 FDA-registered makers in 19 countries

124 establishments in 19 countries are registered with the FDA to make Catheter, Intravascular, Diagnostic (product code DQO, Class 2, 21 CFR 870.1200). 76 of them have a 510(k) clearance or PMA approval on file and 14 have a recall event. The FDA has issued 501 510(k) clearances under this code, the latest on June 26, 2026, and lists 79 recall events (15 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
DQO
Device class
2
Regulation
870.1200
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States61
Mexico18
China8
Ireland5
France5
Costa Rica4
Japan3
Singapore3
Dominican Republic3
Netherlands2
India2
Canada2
Israel2
Switzerland1
Czechia1
Belgium1
Malaysia1
Germany1
South Korea1

Makers of Catheter, Intravascular, Diagnostic

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
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer11March 22, 2019074api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer10July 17, 2025000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer9November 21, 2023052api.fda.gov
Cardinal Health Mexico 244 S de RL de CVCiudad Juarez Chihuahua, MexicoContract manufacturer, Manufacturer8November 21, 2023000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Specification developer7October 29, 2015000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer7November 20, 2009000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer7May 22, 20240140api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler6June 1, 2023000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer5October 29, 2015000api.fda.gov
Bioptimal International Pte. Ltd.SINGAPORE South East, SingaporeManufacturer5May 28, 2026000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer5October 29, 2015000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer5October 29, 2015000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Manufacturer, Specification developer5July 1, 2010000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler5December 22, 2005000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesSpecification developer4December 13, 1994000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer4January 19, 2017000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer4January 6, 2017000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer3July 18, 2018030api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer3July 18, 2018000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer3March 8, 2002000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer3November 26, 2002000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer3August 8, 1995000api.fda.gov
Cook IncorporatedCanton, IL, United StatesManufacturer3October 5, 2018000api.fda.gov
Cordis de Mexico SA de CVCiudad Juarez, Chihuahua Mexico, MexicoManufacturer3August 8, 1995000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer3March 8, 2002000api.fda.gov
Abbott MedicalWestford, MA, United StatesManufacturer2April 14, 2023000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler2November 6, 1989000api.fda.gov
Arrow International C.R. a.s.ZDAR NAD SAZAVOU Vysocina, CzechiaExporter to the US, Manufacturer, Repackager or relabeler2November 6, 1989000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer2November 6, 1989010api.fda.gov
CD LeycomHengelo Overijssel, NetherlandsExporter to the US, Specification developer2December 9, 2003000api.fda.gov
Curatia Medical Co.Sunnyvale, CA, United StatesSpecification developer2March 4, 2013000api.fda.gov
Curatia Medical LimitedSuzhou Jiangsu, ChinaManufacturer2March 4, 2013000api.fda.gov
Enablecv, LLCMidvale, UT, United StatesSpecification developer2February 11, 2011000api.fda.gov
Gentuity, LLCSudbury, MA, United StatesComplaint file establishment, Manufacturer2January 31, 2025010api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer2December 22, 2005020api.fda.gov
Medtronic VascularDanvers, MA, United StatesManufacturer, Specification developer2August 19, 2016030api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesManufacturer2April 2, 1996010api.fda.gov
Phenox LimitedGalway Galway(County), IrelandManufacturer2November 12, 2024000api.fda.gov
Procedure Products, Inc.Vancouver, WA, United StatesManufacturer2November 27, 1991000api.fda.gov
SipvEcouen Ile-de-France, FranceManufacturer2November 27, 1981000api.fda.gov
Spectrum VascularWarren, NJ, United StatesSpecification developer2December 19, 2018000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer2November 22, 2019020api.fda.gov
Stryker NeurovascularSalt Lake City, UT, United StatesManufacturer2November 22, 2019010api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2June 17, 2022000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer2June 17, 2022074api.fda.gov
Vygon S AECOUEN 95440 Val-d'Oise, FranceManufacturer2November 27, 1981000api.fda.gov
Advanced Lifesciences Pvt. Ltd.New Delhi, IndiaExporter to the US, Manufacturer1October 6, 2022000api.fda.gov
Advanced Vascular DynamicsTigard, OR, United StatesManufacturer, Specification developer1July 19, 1983000api.fda.gov
Allwell Medical CorporationRaleigh, NC, United StatesRepackager or relabeler, Specification developer1October 10, 1978000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex, Incorporated)Chelmsford, MA, United StatesContract manufacturer, Manufacturer1November 6, 1989000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1November 2, 1976000api.fda.gov
Biocardia, Inc.Sunnyvale, CA, United StatesManufacturer1January 24, 2002000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer1September 14, 20120113api.fda.gov
Cook, Inc.Bloomington, IN, United StatesManufacturer1November 15, 2017000api.fda.gov
Conavi Medical IncToronto Ontario, CanadaManufacturer1March 28, 2017000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer, Repackager or relabeler1November 25, 1991000api.fda.gov
DimequipFrameries Hainaut, BelgiumManufacturer1November 27, 1981000api.fda.gov
Embolx Inc.Sunnyvale, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 23, 2024000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler1July 1, 2010000api.fda.gov
Imperative Care Inc.Campbell, CA, United StatesComplaint file establishment, Specification developer1April 2, 2024000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1April 16, 1980000api.fda.gov
Merit Medical Singapore Pte. Ltd.SINGAPORE Central Singapore, SingaporeManufacturer1March 16, 1983000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesRepackager or relabeler, Specification developer1August 2, 2012000api.fda.gov
Numed Canada, Inc.CORNWALL Ontario, CanadaManufacturer1April 2, 1996000api.fda.gov
Oscor Inc.Palm Harbor, FL, United StatesComplaint file establishment, Manufacturer1January 13, 2010000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoManufacturer1October 18, 1984000api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.Nuevo Laredo Tamaulipas, MexicoManufacturer1October 18, 1984000api.fda.gov
Shenzhen Antmed Co. LtdDongguan Guangdong, ChinaManufacturer1February 26, 2014000api.fda.gov
SipaAvesnes Sur Helpe Hauts-de-France, FranceManufacturer1November 27, 1981000api.fda.gov
Sunny Medical Device (shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1March 20, 2015000api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer1August 18, 2014000api.fda.gov
Surefire Medical, Inc.Westminster, CO, United StatesComplaint file establishment, Manufacturer1April 3, 2018000api.fda.gov
Terumo Clinical Supply Co., Ltd.Kakamigahara Gifu, JapanManufacturer1December 21, 2021000api.fda.gov
Togo Medikit Co., Ltd.HYUGA CITY Miyazaki, JapanComplaint file establishment, Manufacturer1July 11, 2012000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer1October 18, 1984000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer1June 17, 2022000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Antmed Malaysia Sdn BhdPort Dickson Negeri Sembilan, MalaysiaContract manufacturer0000api.fda.gov
Arrotek Medical LtdCo. Sligo Connaught, IrelandContract manufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0010api.fda.gov
BIOMERICS Advanced CatheterBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
Bioxin Medical Co., LtdWeihai Shandong, ChinaContract manufacturer0000api.fda.gov
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Conod Medical Shuyang Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
CPE1, LLC DBA Greatbatch MedicalSouthwest Ranches, FL, United StatesContract manufacturer0000api.fda.gov
Cirtec MedicalSanta Clara, CA, United StatesContract manufacturer0000api.fda.gov
Creganna Medical S. R. LSan Rafael Heredia, Costa RicaContract manufacturer0000api.fda.gov
Elcam Medical A.C.A.L.D.N. MEROM HAGALIL Northern, IsraelContract manufacturer0000api.fda.gov
Elcam Medical AcalDALTON INDUSTRIAL PARK, P.O BOX 9 Northern, IsraelContract manufacturer0000api.fda.gov
Emerald Medical Services Pte. LtdSingapore North West, SingaporeContract manufacturer0000api.fda.gov
EPIC MedTec OEM Ireland LimitedANNACOTTY Limerick(County), IrelandContract manufacturer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaContract manufacturer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
HexacathRueil Malmaison Ile-de-France, FranceManufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Liquet Medical Inc.Glen Allen, VA, United StatesSpecification developer0000api.fda.gov
Manufacturas Y Servicios Internacionales, S. De R.L.Cd Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer0000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer0000api.fda.gov
Microtek Dominicana, S.A.S.La Romana, Dominican RepublicContract manufacturer0000api.fda.gov
MedFact Engineering GmbHLoerrach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer0000api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov
MicroVention Costa Rica S.R.L.. Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Osi Systems Pvt Ltd(optoelectronics Division)HYDERABAD Telangana, IndiaContract manufacturer0000api.fda.gov
Parallel Design SASValbonne, FranceSpecification developer0000api.fda.gov
Prytime Medical Devices, Inc.Lakewood, CO, United StatesSpecification developer0000api.fda.gov
Parker Industrial S de RL de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Prytime Medical Devices, Inc.Boerne, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Respicardia, Inc.Minnetonka, MN, United StatesSpecification developer0000api.fda.gov
RM Healthcare Products SA de CVJUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shenzhen Vivolight Medical Device&technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sterilization Services Of VirginiaRichmond, VA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Siemens Healthineers Ltd.Pohang-si Gyeongbuk, South KoreaManufacturer, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Unitron Group BVIJzendijke Zeeland, NetherlandsContract manufacturer0000api.fda.gov
Verge Medical Inc.Campbell, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov

Updated June 26, 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.