510(k) Report

FDA applicant

Flir Medical Systems

Portland, OR1 decision1986–19860 recalls

FDA records 1 decision for Flir Medical Systems (Portland, OR) in 1986: 1 510(k) clearance. All are in product code IYM (System, Telethermographic, Infrared). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Flir Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Flir Medical Systems’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 “Flir”

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