Data / Medical devices / Interventional Fluoroscopic X-Ray System

Interventional Fluoroscopic X-Ray System (OWB): 86 FDA-registered makers in 15 countries

86 establishments in 15 countries are registered with the FDA to make Interventional Fluoroscopic X-Ray System (product code OWB, Class 2, 21 CFR 892.1650). 63 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 325 510(k) clearances under this code, the latest on August 21, 2026, and lists 275 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code

OWB

Device class

2

Regulation

892.1650

Medical specialty

Radiology

Makers by country

Makers of Interventional Fluoroscopic X-Ray System

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 21, 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.