FDA applicant

Medivision Medical Imaging, Ltd.

Hopkinton, MA4 decisions1995–20060 recalls

FDA records 4 decisions for Medivision Medical Imaging, Ltd. (Hopkinton, MA) from 1995 to 2006: 4 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 3 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, ophthalmic panel, where it files most

How often FDA has decided Medivision Medical Imaging, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medivision Medical Imaging, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Medivision”

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

Medivision Scope Service Center, Inc. 5 Medivision Endoscopy 1 Medivision (U.S.A.), Inc. 1

Medivision Medical Imaging, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medivision”