Data / Medical devices / Gauze/Sponge, Internal, X-Ray Detectable

Gauze/Sponge, Internal, X-Ray Detectable (GDY): 124 FDA-registered makers in 20 countries

124 establishments in 20 countries are registered with the FDA to make Gauze/Sponge, Internal, X-Ray Detectable (product code GDY, Class 1, 21 CFR 878.4450). 8 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 111 510(k) clearances under this code, the latest on December 17, 1997, and lists 18 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code

GDY

Device class

1

Regulation

878.4450

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Gauze/Sponge, Internal, X-Ray Detectable

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 17, 1997. 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.