Skip to the page

Data / Medical devices / Needle, Conduction, Anesthetic (W/Wo Introducer)

Needle, Conduction, Anesthetic (W/Wo Introducer) (BSP): 63 FDA-registered makers in 18 countries

63 establishments in 18 countries are registered with the FDA to make Needle, Conduction, Anesthetic (W/Wo Introducer) (product code BSP, Class 2, 21 CFR 868.5150). 47 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 152 510(k) clearances under this code, the latest on July 1, 2025, and lists 13 recall events (1 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
BSP
Device class
2
Regulation
868.5150
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States28
Japan7
Mexico6
China5
Germany2
Malaysia2
France2
Spain1
Czechia1
Ireland1
Canada1
India1
Hong Kong1
South Korea1
Dominican Republic1
United Kingdom1
Honduras1
Philippines1

Makers of Needle, Conduction, Anesthetic (W/Wo Introducer)

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
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler12July 1, 2025010api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Contract sterilizer, Repackager or relabeler9June 27, 2014020api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanyExporter to the US, Manufacturer, Specification developer8November 20, 2012000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler6October 31, 2014000api.fda.gov
Epimed International, Inc.Johnstown, NY, United StatesManufacturer, Repackager or relabeler6February 7, 2008010api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer5June 12, 2018000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer5June 12, 2018000api.fda.gov
Unisis CorpKita-Hiroshima-shi Hokkaido, JapanContract manufacturer, Manufacturer5June 12, 2018000api.fda.gov
BD Puerto Rico LLCJuncos, PR, United StatesManufacturer4July 1, 2022000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer4July 1, 2022010api.fda.gov
Becton Dickinson, S.A.SAN AGUSTIN DE GUADALIX Madrid(Province), SpainManufacturer4July 1, 2022000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesManufacturer, Specification developer4September 8, 2017000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer4August 21, 2019010api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer3September 25, 2008000api.fda.gov
Avent S. de R.L. de C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler3September 25, 2008000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer3June 27, 2014000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler3January 5, 2018000api.fda.gov
Hakko Co., Ltd.CHIKUMA-SHI Nagano, JapanManufacturer3April 25, 2007000api.fda.gov
International Medical Development, Inc.Huntsville, UT, United StatesRepackager or relabeler, Specification developer3February 2, 2018000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer2January 8, 1999000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesSpecification developer2August 21, 2019011api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer2June 7, 2018000api.fda.gov
Unisis Corp.Koshigaya-shi Saitama, JapanContract manufacturer, Manufacturer2January 14, 2015000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler1October 19, 1989000api.fda.gov
Aerin Medical Inc.Mountain View, CA, United StatesComplaint file establishment, Specification developer1March 21, 2024000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1January 8, 1999000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaManufacturer1August 21, 2019000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1April 25, 2018010api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Manufacturer for export1June 27, 2017000api.fda.gov
Cook Ireland LtdLIMERICK Limerick(County), IrelandComplaint file establishment, Manufacturer1May 27, 2003000api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaManufacturer1April 22, 2004000api.fda.gov
DR. Japan Co., Ltd.Gyoda City Saitama, JapanManufacturer1June 2, 2000000api.fda.gov
Ever Corp.Nasuhiobara City, TOCHIGI Tokyo, JapanManufacturer1October 9, 1996000api.fda.gov
Global Medikit LimitedDehradun Uttarakhand, IndiaComplaint file establishment, Manufacturer1July 29, 2022000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer1January 25, 2018000api.fda.gov
LCCS Products LimitedSai Ying Pun, Hong KongSpecification developer1December 6, 2013000api.fda.gov
Meditop Corporation (M) Sdn BhdBaru Bangi,Selangor Darul Ehsa, MalaysiaManufacturer1September 19, 1984000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1June 17, 2011000api.fda.gov
Shanghai SA Medical & Plastic Instruments Co., Ltd.Shanghai, ChinaManufacturer1December 21, 2012000api.fda.gov
SipaAvesnes Sur Helpe Hauts-de-France, FranceManufacturer1May 7, 1985000api.fda.gov
Solo-DexWolf Creek, MT, United StatesManufacturer1January 22, 2016000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesSpecification developer1April 5, 2017000api.fda.gov
Tianjin Hanaco Medical Co.,ltd.Tianjin, ChinaManufacturer1June 2, 2000000api.fda.gov
Top CorporationADACHI-KU Tokyo, JapanManufacturer1September 19, 1984000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoExporter to the US, Manufacturer, Repackager or relabeler1October 21, 1991000api.fda.gov
Vygon S AECOUEN 95440 Val-d'Oise, FranceManufacturer1May 7, 1985000api.fda.gov
Zhejiang Kindly Medical Devices Co., LtdWENZHOU Zhejiang, ChinaContract manufacturer, Contract sterilizer, Manufacturer1January 5, 2018000api.fda.gov
B. Braun Aesculap Japan Co., Ltd.Tochigi, JapanContract manufacturer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Custom Tube Manufacturing LLCYangju-si Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
Eagle Labs, LLCSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
G3 MedicalSwannanoa, NC, United StatesContract manufacturer0000api.fda.gov
Gbuk Group LimitedSelby North Yorkshire, United KingdomSpecification developer0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Ispg, Inc.Lakewood Ranch, FL, United StatesContract manufacturer0000api.fda.gov
Ningbo Linstant Polymer Materials Co.,ltdNingbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Philinak Industries IncLIPA Batangas, PhilippinesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Zhejiang Runqiang Medical Instruments Co.,ltd.Jiaxing Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated July 1, 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.