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Data / Medical devices / Needle, Catheter / United States

FDA-registered makers of Needle, Catheter in the United States: 21 establishments

21 establishments in the United States are registered with the FDA to make Needle, Catheter (product code GCB). 2 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Needle, Catheter
Product code
GCB
Country
United States

Makers of Needle, Catheter in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer1June 27, 1985000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1November 12, 2015000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer0010api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Auris Health, IncSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Auris Health, Inc.San Jose, CA, United StatesManufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Galt Medical Corp.Garland, TX, United StatesManufacturer0000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
PFM Medical, IncCarlsbad, CA, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Safeguard Us Operating, LLCHuntersville, NC, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
UTP SolutionsEvart, MI, United StatesContract manufacturer0000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov

Updated November 3, 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.