510(k) Report

FDA applicant

Milliken Healthcare Products, LLC

Spartanburg, SC3 decisions2011–20140 recalls

FDA records 3 decisions for Milliken Healthcare Products, LLC (Spartanburg, SC) from 2011 to 2014: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and FRL (Fiber, Medical, Absorbent). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 hospital panel, where it files most

How often FDA has decided Milliken Healthcare Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 22014: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Milliken Healthcare Products, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Milliken”

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