FDA applicant

Thermo Electron OY

Vantaa, FI14 decisions2004–20070 recalls

FDA records 14 decisions for Thermo Electron OY (Vantaa, FI) from 2004 to 2007: 14 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DIP (Enzyme Immunoassay, Diphenylhydantoin). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Thermo-Electron Corp.”, “Thermo Electron Corporation”, “Thermo Electron Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

10in 2007

2007high 10 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Thermo”

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

Thermo Fisher Scientific 65 Thermo Biostar, Inc. 5 Thermo Dma, Inc. 4 Thermo Temp, Inc. 4 Thermo Fisher Scientific (Oxoid Ltd.) 3 Thermo Orion 3 Thermo Bioanalysis Corp. 2 Thermo Fisher Scientific (Nalge Nunc Intl) 1 Thermo-Mold Medical Products, Inc. 1 Thermo Fisher Scientific (Life Technologies Holdin 1 Thermo Forma, Inc. 1 Thermo Body Wrap Systems, Inc. 1

Thermo Electron OY

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 “Thermo”