FDA applicant

Bristol Medical Electronics Corp.

Mansfield, MA2 decisions1985–19850 recalls

FDA records 2 decisions for Bristol Medical Electronics Corp. (Mansfield, MA) in 1985: 2 510(k) clearances. All are in product code DRX (Electrode, Electrocardiograph). 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, cardiovascular panel, where it files most

How often FDA has decided Bristol Medical Electronics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bristol Medical Electronics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Bristol”

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

Bristol-Myers Squibb 1

Bristol Medical Electronics Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bristol”