510(k) Report

FDA applicant

Gabriel Ent.

Mchenry, IL2 decisions1982–19830 recalls

FDA records 2 decisions for Gabriel Ent. (Mchenry, IL) from 1982 to 1983: 2 510(k) clearances. All are in product code HCS (Device, Temperature Measurement, Direct…). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Gabriel Ent. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Gabriel”

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