Data / Medical devices / Syringe, Piston

Syringe, Piston (FMF): 308 FDA-registered makers in 39 countries

308 establishments in 39 countries are registered with the FDA to make Syringe, Piston (product code FMF, Class 2, 21 CFR 880.5860). 180 of them have a 510(k) clearance or PMA approval on file and 18 have a recall event. The FDA has issued 752 510(k) clearances under this code, the latest on August 26, 2026, and lists 96 recall events (6 Class I). FDA data exported November 2, 2026.

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Product code

FMF

Device class

2

Regulation

880.5860

Medical specialty

General Hospital

Makers by country

Makers of Syringe, Piston

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 August 26, 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.