Skip to the page
Get started – free

Data / Medical devices / Midline Catheter

Midline Catheter (PND): 16 FDA-registered makers in 3 countries

16 establishments in 3 countries are registered with the FDA to make Midline Catheter (product code PND, Class 2, 21 CFR 880.5200). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on December 18, 2025, and lists 7 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.

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

Makers by country

CountryMakers
United States12
Mexico3
China1

Makers of Midline Catheter

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
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer4May 13, 2022010api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler2September 2, 2022000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer2September 2, 2022010api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer2August 27, 2021000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer, Manufacturer1May 13, 2022000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1July 25, 2017000api.fda.gov
PFM Medical, IncCarlsbad, CA, United StatesComplaint file establishment, Manufacturer1March 7, 2018000api.fda.gov
Terumo Medical Products (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer1December 18, 2025000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer1November 2, 2018010api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Atl Technology LLCSpringville, UT, United StatesContract manufacturer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Nuwellis, Inc.Eden Prairie, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Spectrum VascularWarren, NJ, United StatesManufacturer, Specification developer0000api.fda.gov

Updated December 18, 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.