510(k) Report

FDA applicant

Medibell Medical Vision Technologies, Ltd.

Haifa, IL1 decision2004–20040 recalls

FDA records 1 decision for Medibell Medical Vision Technologies, Ltd. (Haifa, IL) in 2004: 1 510(k) clearance. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 1 predicate, 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, ophthalmic panel, where it files most

How often FDA has decided Medibell Medical Vision Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medibell Medical Vision Technologies, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HKICamera, Ophthalmic, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K040325Panoret, Model PNM 60Medibell Medical Vision Technologies, Ltd. · 2004

The one decision as Medibell Medical Vision Technologies, Ltd. →