FDA applicant

Koninklijke (Royal) Utermohlen

Wolvega, NL1 decision2015–20150 recalls

FDA records 1 decision for Koninklijke (Royal) Utermohlen (Wolvega, NL) in 2015: 1 510(k) clearance. All are in product code GEH (Unit, Cryosurgical, Accessories). 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 Koninklijke (Royal) Utermohlen’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Koninklijke (Royal) Utermohlen by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Koninklijke (Royal) Utermohlen’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Koninklijke”

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

Koninklijke Utermohlen NV 2

Koninklijke (Royal) Utermohlen

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Koninklijke”