FDA applicant

Allen Medical Systems, Inc.

Bedford Heights, OH5 decisions1993–19970 recalls

FDA records 5 decisions for Allen Medical Systems, Inc. (Bedford Heights, OH) from 1993 to 1997: 5 510(k) clearances. Most are in product codes FWZ (Operating Room Accessories Table Tray) and GDC (Table, Operating-Room, Electrical). 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 Allen Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Allen Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Allen 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.

See the 510(k) Report

Other applicant names beginning “Allen”

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

Allen J. Moses, Dds, Ltd. 4 The Allen Products Co. 3 Allen Medical Instruments Corp. 1

Allen Medical Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Allen”