FDA applicant

Berkeley Bio-Medical, Inc.

Mchenry, IL2 decisions1978–19780 recalls

FDA records 2 decisions for Berkeley Bio-Medical, Inc. (Mchenry, IL) in 1978: 2 510(k) clearances. Most are in product codes GDJ (Clamp, Surgical, General & Plastic Surgery) and GAD (Retractor). 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 Berkeley Bio-Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Berkeley Bio-Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Berkeley Bio-Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Berkeley”

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

Berkeley Advanced Biomaterials, Inc. 16 Berkeley Electric Wheelchair Co. 6 Berkeley Medevices 5 Berkeley Bio-Engineering 4

Berkeley Bio-Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Berkeley”