FDA applicant

Engineered Medical Solutions Co., LLC

Leola, PA2 decisions2007–20130 recalls

FDA records 2 decisions for Engineered Medical Solutions Co., LLC (Leola, PA) from 2007 to 2013: 2 510(k) clearances. All are in product code FTD (Lamp, Surgical). Its devices cite 3 predicates, 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Engineered Medical Solutions Co., LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Engineered Medical Solutions Co., LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Engineered Medical Solutions Co., LLC’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 “Engineered”

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

Engineered Medical Systems 24 Engineered Orthopedic Technologies, Inc. 2 Engineered Medical Technology, Inc. 1 Engineered Tissue Solutions, LLC 1 Engineered Endodontics 1 Engineered Custom Mfg., Inc. 1

Engineered Medical Solutions Co., LLC

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 “Engineered”