FDA applicant

Concord Medical Products

Burlington, MA1 decision2010–20100 recalls

FDA records 1 decision for Concord Medical Products (Burlington, MA) in 2010: 1 510(k) clearance. All are in product code MKJ (Automated External Defibrillators (Non-Wearable)). 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, cardiovascular panel, where it files most

How often FDA has decided Concord Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Concord Medical Products by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Concord Medical Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Concord”

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

Concord Laboratories, Inc. 42 Concord/Portex 23 Concord Imaging, Ltd. 1 Concord Protex 1

Concord Medical Products

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Concord”