FDA applicant

Roeko

Mchenry, IL1 decision1982–19820 recalls

FDA records 1 decision for Roeko (Mchenry, IL) in 1982: 1 510(k) clearance. All are in product code EKN (Point, Paper, Endodontic). 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, dental panel, where it files most

How often FDA has decided Roeko’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Roeko since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Roeko”

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

Roeko Ulm, Roescheisen GmbH & Co. 1 Roeko USA, Inc. 1

Roeko

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Roeko”