510(k) Report

FDA applicant

Meridian Medical Systems, LLC

Aurora, OH8 decisions1994–20160 recalls

FDA records 8 decisions for Meridian Medical Systems, LLC (Aurora, OH) from 1994 to 2016: 8 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and IZL (System, X-Ray, Mobile). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Meridian Medical Systems, Inc.”.

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 Meridian Medical Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12012: 22014: 12015: 12016: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Meridian Medical Systems, LLC’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 “Meridian”

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