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Data / Medical devices / Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ): 102 FDA-registered makers in 23 countries

102 establishments in 23 countries are registered with the FDA to make Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ, Class 2, 21 CFR 880.5200). 81 of them have a 510(k) clearance or PMA approval on file and 13 have a recall event. The FDA has issued 508 510(k) clearances under this code, the latest on September 2, 2026, and lists 92 recall events (5 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
FOZ
Device class
2
Regulation
880.5200
Medical specialty
General Hospital

Makers by country

CountryMakers
United States39
Mexico12
China11
Japan5
India4
Italy3
Singapore3
South Korea3
Costa Rica3
Czechia2
Germany2
Thailand2
France2
Canada2
Denmark1
Egypt1
Brazil1
Ireland1
Philippines1
Portugal1
Malaysia1
Dominican Republic1
Indonesia1

Makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler18March 14, 2025000api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesManufacturer, Specification developer15April 2, 20260110api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer10March 14, 20250311api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer10July 29, 2024020api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer10May 17, 2019060api.fda.gov
Arrow International C.R. a.s.ZDAR NAD SAZAVOU Vysocina, CzechiaExporter to the US, Manufacturer, Repackager or relabeler8June 12, 2014000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler7February 8, 2021000api.fda.gov
MedSource Labs, LLCChanhassen, MN, United StatesComplaint file establishment, Specification developer7July 10, 2026000api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanySpecification developer6May 15, 2026000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer6June 30, 2016000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler6August 30, 2007000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaManufacturer5August 30, 2007000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler5July 23, 2021000api.fda.gov
Poly Medicure Ltd.Faridabad Haryana, IndiaManufacturer5April 1, 2026000api.fda.gov
Spectrum VascularWarren, NJ, United StatesManufacturer, Specification developer5May 17, 2019000api.fda.gov
VYGON Germany GmbHAACHEN North Rhine-Westphalia, GermanyManufacturer5July 30, 2014000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer5August 29, 2022010api.fda.gov
ICU Medical, Inc.Southington, CT, United StatesManufacturer4June 30, 2016000api.fda.gov
Nipro (Thailand) Corporation LimitedSENA Phra Nakhon Si Ayutthaya, ThailandContract manufacturer, Manufacturer4March 8, 2017000api.fda.gov
Vygon S AECOUEN 95440 Val-d'Oise, FranceContract sterilizer, Manufacturer4November 30, 2007000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer3March 22, 1995000api.fda.gov
Delta Med SpAviadana Mantova, ItalyExporter to the US, Manufacturer3August 26, 2020010api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer3March 22, 1995000api.fda.gov
Skydance Vascular, Inc.Pleasant Grove, UT, United StatesComplaint file establishment, Specification developer3May 2, 2025000api.fda.gov
Togo Medikit Co., Ltd.HYUGA CITY Miyazaki, JapanComplaint file establishment, Exporter to the US, Manufacturer3September 20, 2019000api.fda.gov
Togo Medikit Co., Ltd. Medikit Hyuga Second FactoryHyuga City Miyazaki, JapanManufacturer3September 20, 2019000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer3August 29, 2022000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer2January 23, 2002050api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaManufacturer2September 20, 2002000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoContract manufacturer, Manufacturer2May 17, 1985000api.fda.gov
Delta Med SpASorbolo Levante di Brescello Reggio Emilia, ItalyManufacturer2August 26, 2020000api.fda.gov
Haolang Medical Usa CorporationClyde Hill, WA, United StatesSpecification developer2August 20, 2014000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesManufacturer, Manufacturer for export2March 12, 2020000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler2July 23, 2021000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoManufacturer2March 11, 2016000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer2June 30, 2016000api.fda.gov
Kofu Factory Of Terumo Corp.NAKAKOMA-GUN Yamanashi, JapanManufacturer2February 26, 2010000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2February 23, 2001000api.fda.gov
SipvEcouen Ile-de-France, FranceManufacturer2November 30, 2007000api.fda.gov
Unomedical A/SOSTED, LEJRE Sjaelland, DenmarkComplaint file establishment, Specification developer2February 16, 2012000api.fda.gov
Access Vascular, IncBillerica, MA, United StatesManufacturer1March 27, 2025030api.fda.gov
Ameco Medical Industries10TH OF RAMADAN CITY Ash Sharqiyah, EgyptManufacturer1December 21, 2011000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer, Repackager or relabeler1April 14, 2006000api.fda.gov
Becton Dickinson Industrias Cirurgicas, Ltda.JUIZ DE FORA Minas Gerais, BrazilManufacturer1July 27, 2015000api.fda.gov
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.NOGALES Sonora, MexicoContract manufacturer, Manufacturer1July 27, 2015000api.fda.gov
Becton Dickinson Medical (singapore)SINGAPORE North West, SingaporeContract manufacturer, Contract sterilizer, Manufacturer1July 27, 2015000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer1December 30, 2003000api.fda.gov
Bioptimal International Pte. Ltd.SINGAPORE South East, SingaporeManufacturer1November 17, 2000000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer1May 18, 2012011api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler1May 18, 2012010api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1October 2, 1991000api.fda.gov
Derma Sciences Canada, IncTORONTO Ontario, CanadaManufacturer1April 20, 2000000api.fda.gov
Ecomed Solutions, LLCLindenhurst, IL, United StatesComplaint file establishment, Specification developer1August 7, 2009000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesContract manufacturer, Manufacturer1December 30, 2003020api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer1February 16, 1990000api.fda.gov
Foshan Special Medical Co., LtdFOSHAN CITY Guangdong, ChinaManufacturer1January 7, 2003000api.fda.gov
Guangdong Baihe Medical Technology Co., LtdFoshan Guangdong, ChinaExporter to the US, Manufacturer1July 31, 2007000api.fda.gov
Hindustan Syringes & Medical Devices Ltd.Faridabad Haryana, IndiaManufacturer1November 26, 1996000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer1February 10, 1997000api.fda.gov
ICU Medical (SM Prodotti) Italia S.r.L.Latina Scalo - LT, ItalyManufacturer1August 20, 1999000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer1May 5, 1994000api.fda.gov
Jiangxi Sanxin Medtec Co.,ltd.Nanchang Jiangxi, ChinaExporter to the US, Manufacturer1June 18, 2015000api.fda.gov
JMS Singapore Pte. LtdSINGAPORE Central Singapore, SingaporeManufacturer1August 18, 2003000api.fda.gov
Kawasumi Laboratories (thailand) Co., Ltd.CHOK CHAI Nakhon Ratchasima, ThailandManufacturer1July 13, 1993000api.fda.gov
Luther Needlesafe Products LLCLaguna Hills, CA, United StatesManufacturer1April 30, 2013000api.fda.gov
Mediplus (india) LimitedBahadurgarh Haryana, IndiaManufacturer1March 25, 2022000api.fda.gov
Mallinckrodt MedicalATHLONE Westmeath, IrelandContract manufacturer, Contract sterilizer, Repackager or relabeler1October 14, 1994000api.fda.gov
Medifirst Co.,Ltd.Cheonan-si, Chungnam, South KoreaManufacturer1April 23, 2020000api.fda.gov
Nipro Corporation Odate FactoryODATE-SHI Akita, JapanManufacturer1March 28, 1996000api.fda.gov
Nipro Medical Industries Ltd.TATEBAYASHI-SHI Gunma, JapanManufacturer1December 5, 2013000api.fda.gov
Primrose Medical, Inc.East Walpole, MA, United StatesManufacturer1August 4, 1988000api.fda.gov
Quiroproductos de Cuauhtemoc S. De R.L. de C.V.Cuauhtemoc Chihuahua, MexicoManufacturer1October 2, 1991000api.fda.gov
Retractable Technologies, Inc.Little Elm, TX, United StatesComplaint file establishment, Manufacturer1November 7, 2008000api.fda.gov
Shinchang Medical Co., Ltd.Gumi-si Gyeongbuk, South KoreaManufacturer1October 16, 2007000api.fda.gov
Shandong Ande Healthcare Apparatus Co., Ltd.Zibo Shandong, ChinaManufacturer1July 23, 2021000api.fda.gov
Terumo (philippines) CorporationBINAN Laguna, PhilippinesManufacturer1June 12, 2014000api.fda.gov
Terumo Medical Products (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer1December 17, 2025000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler1May 18, 2012000api.fda.gov
Venocare, Inc.Doral, FL, United StatesComplaint file establishment, Specification developer1May 16, 2025000api.fda.gov
Vygon PortugalBalter-Paredes Porto, PortugalManufacturer1September 9, 1997000api.fda.gov
Wooyoung Medical Co LtdJincheon-gun Chungbuk, South KoreaComplaint file establishment, Manufacturer1September 13, 2022000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Amsino Medical (shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesContract manufacturer0010api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer, Contract sterilizer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Contract sterilizer0010api.fda.gov
Bioxin Medical Co., LtdWeihai Shandong, ChinaContract manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Becton Dickinson Medical Devices Co., Ltd. SuzhouSuzhou Jiangsu, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Cardinal Health Costa Rica, S.A.-- Alajuela, Costa RicaContract manufacturer, Manufacturer0000api.fda.gov
Freudenberg Medical, SRLLa Garita Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Haolang Technology (foshan) Limited CorporationFoshan Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Harsoria Healthcare Pvt. Ltd.Gurgoon Haryana, IndiaContract manufacturer, Contract sterilizer0000api.fda.gov
ItekCartago, Costa RicaContract manufacturer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Novem Medical S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Oscor Caribe LLCSANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer, Contract sterilizer0000api.fda.gov
PT JMS BatamBATAM Kepulauan Riau, IndonesiaContract manufacturer0000api.fda.gov
Unomedical Devices S.A de C.VReynosa Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Weihai Jierui Medical Products Co., Ltd.WEIHAI Shandong, ChinaContract manufacturer0000api.fda.gov
Zhejiang Kindly Medical Devices Co., LtdWENZHOU Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov

Updated September 2, 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.