FDA applicant

Thermo Orion

Beverly, MA3 decisions1982–20030 recalls

FDA records 3 decisions for Thermo Orion (Beverly, MA) from 1982 to 2003: 3 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and JGS (Electrode, Ion Specific, Sodium). Its devices cite 1 predicate, 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Thermo Orion since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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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 Electron OY 14 Thermo Biostar, Inc. 5 Thermo Dma, Inc. 4 Thermo Temp, Inc. 4 Thermo Fisher Scientific (Oxoid Ltd.) 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 Orion

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Thermo”