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Data / Medical devices / Non-Coring (Huber) Needle

Non-Coring (Huber) Needle (PTI): 14 FDA-registered makers in 6 countries

14 establishments in 6 countries are registered with the FDA to make Non-Coring (Huber) Needle (product code PTI, Class 2, 21 CFR 880.5570). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on September 18, 2026, and lists 1 recall event (0 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
PTI
Device class
2
Regulation
880.5570
Medical specialty
General Hospital

Makers by country

CountryMakers
United States6
China3
Mexico2
France1
Thailand1
Malaysia1

Makers of Non-Coring (Huber) Needle

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 StatesComplaint file establishment, Manufacturer, Specification developer2November 27, 2024000api.fda.gov
Intera OncologyNewton, MA, United StatesSpecification developer2March 16, 2022000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Specification developer2April 7, 2021000api.fda.gov
Promisemed Hangzhou Meditech Co.,ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer2May 13, 2025000api.fda.gov
B. Braun MedicalCHASSENEUIL-DU-POITOU Vienne, FranceSpecification developer1November 3, 2017000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer, Repackager or relabeler1August 8, 2017000api.fda.gov
Jiangsu Caina Medical Co., LtdJiangyin Jiangsu, ChinaManufacturer1April 7, 2021000api.fda.gov
Kawasumi Laboratories (thailand) Co., Ltd.CHOK CHAI Nakhon Ratchasima, ThailandManufacturer1November 26, 2025000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoComplaint file establishment, Contract manufacturer, Manufacturer1September 18, 2026000api.fda.gov
Multi-Med, Inc.Keene, NH, United StatesManufacturer1December 14, 2017000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Forefront Medical Technology (jiangsu) Co.,ltdChangzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
VLV Associates, Inc.Whippany, NJ, United StatesContract manufacturer0000api.fda.gov

Updated September 18, 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.