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Data / Medical devices / Catheter, Conduction, Anesthetic

Catheter, Conduction, Anesthetic (BSO): 33 FDA-registered makers in 9 countries

33 establishments in 9 countries are registered with the FDA to make Catheter, Conduction, Anesthetic (product code BSO, Class 2, 21 CFR 868.5120). 25 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 75 510(k) clearances under this code, the latest on February 13, 2025, and lists 11 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
BSO
Device class
2
Regulation
868.5120
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States13
Mexico7
Germany3
Czechia3
South Korea2
United Kingdom2
Denmark1
Italy1
China1

Makers of Catheter, Conduction, Anesthetic

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 developer7September 30, 2016010api.fda.gov
Avent S. de R.L. de C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler7September 30, 2016000api.fda.gov
Epimed International, Inc.Johnstown, NY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer5April 27, 2020020api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer3September 15, 2023000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer3October 18, 2006000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer3October 18, 2006000api.fda.gov
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer3May 3, 2018000api.fda.gov
Axiom Medical, Inc.Torrance, CA, United StatesManufacturer2May 17, 2000000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler2March 17, 2017000api.fda.gov
Arrow International C.R. a.s.ZDAR NAD SAZAVOU Vysocina, CzechiaExporter to the US, Manufacturer2March 17, 2017000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaExporter to the US, Manufacturer2March 17, 2017000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesSpecification developer2March 17, 2017021api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer2March 17, 2017030api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanyExporter to the US, Manufacturer, Specification developer2June 29, 2009000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Repackager or relabeler2June 29, 2009010api.fda.gov
Imedicom Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer2August 24, 2018000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer2March 4, 2019000api.fda.gov
BD Puerto Rico LLCJuncos, PR, United StatesManufacturer1March 11, 1985000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer1March 11, 1985000api.fda.gov
Cimpax A/SSlangerup Hovedstaden, DenmarkManufacturer, Specification developer1October 25, 2019000api.fda.gov
JMT Co., Ltd.Yangju-si Gyeonggi, South KoreaManufacturer1February 13, 2025000api.fda.gov
Meridian Medical LimitedLittlehampton West Sussex, United KingdomManufacturer, Repackager or relabeler1July 7, 2005000api.fda.gov
Plan 1 Health SRLAmaro Udine, ItalyManufacturer1July 8, 2011000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1January 19, 2011000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoContract manufacturer, Manufacturer1February 27, 1984000api.fda.gov
CIMPAX CZ s.r.o.Vyskov, CzechiaContract manufacturer0000api.fda.gov
Gbuk Group LimitedSelby North Yorkshire, United KingdomSpecification developer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
RAUMEDIC - MuenchbergHelmbrechts Bavaria, GermanyContract manufacturer0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer, Contract sterilizer0000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Zhejiang Runqiang Medical Instruments Co.,ltd.Jiaxing Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated February 13, 2025. 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.