FDA applicant

The Western Diagnostics Co.

West Palm Beach, FL1 decision1993–19930 recalls

FDA records 1 decision for The Western Diagnostics Co. (West Palm Beach, FL) in 1993: 1 510(k) clearance. All are in product code IQK (Orthosis, Cervical). 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, physical medicine panel, where it files most

How often FDA has decided The Western Diagnostics Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Western Diagnostics Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like The Western Diagnostics Co.’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 “The”

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

Western Laboratories Corp. 7 Western Advanced Technology, Inc. 6 Western Medical, Ltd. 4 Western Medical Products, Inc. 3 Western Systems Research, Inc. 2 Western M/D, Inc. 2 Western Surgical Instrument Co. 1 Western Medical Equipment Corp. 1 Western/Scott Fetzer Co. 1 Western Systems, Inc. 1 Western Medical Research 1 Western Dialysis Supplies, Ltd. 1

The Western Diagnostics Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “The”