FDA applicant

Soredex Palodex Group OY

Tuusula, FI9 decisions2001–20114 recalls

FDA records 9 decisions for Soredex Palodex Group OY (Tuusula, FI) from 2001 to 2011: 9 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and EHD (Unit, X-Ray, Extraoral With Timer). Its devices cite 13 predicates, 3 of them its own earlier devices. 4 recalls are 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 Soredex Palodex Group OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2020

2007high 4 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Soredex Palodex Group OY’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 “Soredex”

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

Soredex, Inc. 1 Soredex Medical Systems 1

Soredex Palodex Group OY

Which product codes does it file in?

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Other applicant names beginning “Soredex”