510(k) Report

FDA applicant

Bard Electro Medical Systems, Inc.

Englewood, CO1 decision1988–19880 recalls

FDA records 1 decision for Bard Electro Medical Systems, Inc. (Englewood, CO) in 1988: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Bard Electro Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bard Electro Medical Systems, Inc.’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 “Bard”

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