FDA applicant

Merlin Engineering Works, Inc.

Palo Alto, CA8 decisions1995–19980 recalls

FDA records 8 decisions for Merlin Engineering Works, Inc. (Palo Alto, CA) from 1995 to 1998: 8 510(k) clearances. Most are in product codes LMD (System, Digital Image Communications…) and LLZ (System, Image Processing, Radiological). Its devices cite 9 predicates, 6 of them its own earlier devices. 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, radiology panel, where it files most

How often FDA has decided Merlin Engineering Works, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Merlin Engineering Works, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Merlin Engineering Works, 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 “Merlin”

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

Merlin Medical Limited 2 The Merlin Corp. 2 Merlin Group Dba Mcmerlin Dental Company 1

Merlin Engineering Works, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Merlin”