FDA applicant

Coloplast Manufacturing Us, LLC

Minneapolis, MN4 decisions2007–20100 recalls

FDA records 4 decisions for Coloplast Manufacturing Us, LLC (Minneapolis, MN) from 2007 to 2010: 4 510(k) clearances. Most are in product codes OTM (Mesh, Surgical, For Stress Urinary…) and EZD (Catheter, Straight). 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 and plastic surgery panel, where it files most

How often FDA has decided Coloplast Manufacturing Us, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2007high 2 (2010) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coloplast Manufacturing Us, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Coloplast”

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

Coloplast Corp. 73 Coloplast A/S 71

Coloplast Manufacturing Us, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Coloplast”