FDA applicant

Edge Medical Devices, Ltd.

Raanana, IL1 decision2006–20060 recalls

FDA records 1 decision for Edge Medical Devices, Ltd. (Raanana, IL) in 2006: 1 510(k) clearance. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 2 predicates, 0 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 Edge Medical Devices, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Edge Medical Devices, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Edge Medical Devices, Ltd.’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 “Edge”

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

Edge Systems Corp. 3 Edge Medical, LLC 1 Edge Biologicals, Inc. 1

Edge Medical Devices, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Edge”