Data / Medical devices / Rongeur

Rongeur (HTX): 258 FDA-registered makers in 21 countries

258 establishments in 21 countries are registered with the FDA to make Rongeur (product code HTX, Class 1, 21 CFR 888.4540). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on December 30, 1987, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

HTX

Device class

1

Regulation

888.4540

Medical specialty

Orthopedic

Makers by country

Makers of Rongeur

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 December 30, 1987. 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.