FDA applicant

Western Ent.

Westlake, OH1 decision2001–20013 recalls

FDA records 1 decision for Western Ent. (Westlake, OH) in 2001: 1 510(k) clearance. All are in product code NFB (Conserver, Oxygen). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Western Ent. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Western”

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 The Western Diagnostics Co. 1 Western Medical Research 1

Western Ent.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Western”