Data / Medical devices / Needle, Hypodermic, Single Lumen

Needle, Hypodermic, Single Lumen (FMI): 242 FDA-registered makers in 35 countries

242 establishments in 35 countries are registered with the FDA to make Needle, Hypodermic, Single Lumen (product code FMI, Class 2, 21 CFR 880.5570). 148 of them have a 510(k) clearance or PMA approval on file and 18 have a recall event. The FDA has issued 694 510(k) clearances under this code, the latest on September 17, 2026, and lists 78 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code

FMI

Device class

2

Regulation

880.5570

Medical specialty

General Hospital

Makers by country

Makers of Needle, Hypodermic, Single Lumen

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.

Updated September 17, 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.