510(k) Report

FDA applicant

Debusk Knitting Mills, Div. Deroyal Industries

Powell, TN4 decisions1996–19960 recalls

FDA records 4 decisions for Debusk Knitting Mills, Div. Deroyal Industries (Powell, TN) in 1996: 4 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and MPO (Infant Heel Warmer (Chemical Heat Pack)). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Debusk Knitting Mills, Div. Deroyal Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Debusk Knitting Mills, Div. Deroyal Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Debusk Knitting Mills, Div. Deroyal Industries by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Debusk”

FDA records each applicant name separately; these may or may not be the same firm.