Data / Medical devices / Staple, Implantable

Staple, Implantable (GDW): 75 FDA-registered makers in 10 countries

75 establishments in 10 countries are registered with the FDA to make Staple, Implantable (product code GDW, Class 2, 21 CFR 878.4750). 38 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 284 510(k) clearances under this code, the latest on September 25, 2026, and lists 58 recall events (5 Class I). FDA data exported November 3, 2026.

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Product code

GDW

Device class

2

Regulation

878.4750

Medical specialty

General, Plastic Surgery

Implant

Yes

Makers by country

Makers of Staple, Implantable

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 25, 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.