Data / Medical devices / Elastomer, Silicone, For Scar Management

Elastomer, Silicone, For Scar Management (MDA): 155 FDA-registered makers in 18 countries

155 establishments in 18 countries are registered with the FDA to make Elastomer, Silicone, For Scar Management (product code MDA, Class 1, 21 CFR 878.4025). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 81 510(k) clearances under this code, the latest on September 29, 2011, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

MDA

Device class

1

Regulation

878.4025

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Elastomer, Silicone, For Scar Management

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 29, 2011. 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.