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.
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- Product code
- BSP
- Device class
- 2
- Regulation
- 868.5150
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 28 |
| Japan | 7 |
| Mexico | 6 |
| China | 5 |
| Germany | 2 |
| Malaysia | 2 |
| France | 2 |
| Spain | 1 |
| Czechia | 1 |
| Ireland | 1 |
| Canada | 1 |
| India | 1 |
| Hong Kong | 1 |
| South Korea | 1 |
| Dominican Republic | 1 |
| United Kingdom | 1 |
| Honduras | 1 |
| Philippines | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Pajunk GMBH Medizintechnologie | GEISINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | 12 | July 1, 2025 | 0 | 1 | 0 | api.fda.gov |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer, Contract sterilizer, Repackager or relabeler | 9 | June 27, 2014 | 0 | 2 | 0 | api.fda.gov |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Exporter to the US, Manufacturer, Specification developer | 8 | November 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 6 | October 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Epimed International, Inc. | Johnstown, NY, United States | Manufacturer, Repackager or relabeler | 6 | February 7, 2008 | 0 | 1 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 5 | June 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 5 | June 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Unisis Corp | Kita-Hiroshima-shi Hokkaido, Japan | Contract manufacturer, Manufacturer | 5 | June 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| BD Puerto Rico LLC | Juncos, PR, United States | Manufacturer | 4 | July 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 4 | July 1, 2022 | 0 | 1 | 0 | api.fda.gov |
| Becton Dickinson, S.A. | SAN AGUSTIN DE GUADALIX Madrid(Province), Spain | Manufacturer | 4 | July 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Spectra Medical Devices, LLC | Wilmington, MA, United States | Manufacturer, Specification developer | 4 | September 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 4 | August 21, 2019 | 0 | 1 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 3 | September 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| Avent S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 3 | September 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 3 | June 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer, Repackager or relabeler | 3 | January 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hakko Co., Ltd. | CHIKUMA-SHI Nagano, Japan | Manufacturer | 3 | April 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| International Medical Development, Inc. | Huntsville, UT, United States | Repackager or relabeler, Specification developer | 3 | February 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer, Manufacturer | 2 | January 8, 1999 | 0 | 0 | 0 | api.fda.gov |
| Arrow International LLC (subsidiary of Teleflex Incorporated) | Morrisville, NC, United States | Specification developer | 2 | August 21, 2019 | 0 | 1 | 1 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 2 | June 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Unisis Corp. | Koshigaya-shi Saitama, Japan | Contract manufacturer, Manufacturer | 2 | January 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler | 1 | October 19, 1989 | 0 | 0 | 0 | api.fda.gov |
| Aerin Medical Inc. | Mountain View, CA, United States | Complaint file establishment, Specification developer | 1 | March 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | January 8, 1999 | 0 | 0 | 0 | api.fda.gov |
| Arrow International CR, a.s. | Hradec Kralove, Czechia | Manufacturer | 1 | August 21, 2019 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | April 25, 2018 | 0 | 1 | 0 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer for export | 1 | June 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cook Ireland Ltd | LIMERICK Limerick(County), Ireland | Complaint file establishment, Manufacturer | 1 | May 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| Canadian Hospital Specialties Ltd. | OAKVILLE Ontario, Canada | Manufacturer | 1 | April 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| DR. Japan Co., Ltd. | Gyoda City Saitama, Japan | Manufacturer | 1 | June 2, 2000 | 0 | 0 | 0 | api.fda.gov |
| Ever Corp. | Nasuhiobara City, TOCHIGI Tokyo, Japan | Manufacturer | 1 | October 9, 1996 | 0 | 0 | 0 | api.fda.gov |
| Global Medikit Limited | Dehradun Uttarakhand, India | Complaint file establishment, Manufacturer | 1 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 1 | January 25, 2018 | 0 | 0 | 0 | api.fda.gov |
| LCCS Products Limited | Sai Ying Pun, Hong Kong | Specification developer | 1 | December 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Meditop Corporation (M) Sdn Bhd | Baru Bangi,Selangor Darul Ehsa, Malaysia | Manufacturer | 1 | September 19, 1984 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | June 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shanghai SA Medical & Plastic Instruments Co., Ltd. | Shanghai, China | Manufacturer | 1 | December 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Sipa | Avesnes Sur Helpe Hauts-de-France, France | Manufacturer | 1 | May 7, 1985 | 0 | 0 | 0 | api.fda.gov |
| Solo-Dex | Wolf Creek, MT, United States | Manufacturer | 1 | January 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Specification developer | 1 | April 5, 2017 | 0 | 0 | 0 | api.fda.gov |
| Tianjin Hanaco Medical Co.,ltd. | Tianjin, China | Manufacturer | 1 | June 2, 2000 | 0 | 0 | 0 | api.fda.gov |
| Top Corporation | ADACHI-KU Tokyo, Japan | Manufacturer | 1 | September 19, 1984 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | October 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer | 1 | May 7, 1985 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Kindly Medical Devices Co., Ltd | WENZHOU Zhejiang, China | Contract manufacturer, Contract sterilizer, Manufacturer | 1 | January 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Aesculap Japan Co., Ltd. | Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical Industries Sdn. Bhd. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Custom Tube Manufacturing LLC | Yangju-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eagle Labs, LLC | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G3 Medical | Swannanoa, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gbuk Group Limited | Selby North Yorkshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hart Enterprises, Inc. | Sparta, MI, United States | 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 | |
| Ispg, Inc. | Lakewood Ranch, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Linstant Polymer Materials Co.,ltd | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philinak Industries Inc | LIPA Batangas, Philippines | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranfac Corp. | Avon, MA, United States | Contract 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 | |
| Zhejiang Runqiang Medical Instruments Co.,ltd. | Jiaxing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.