FDA applicant

Or-Nim Medical, Ltd.

Kfar Saba, IL5 decisions2008–20150 recalls

FDA records 5 decisions for Or-Nim Medical, Ltd. (Kfar Saba, IL) from 2008 to 2015: 5 510(k) clearances. Most are in product codes MUD (Oximeter, Tissue Saturation) and DPW (Flowmeter, Blood, Cardiovascular). Its devices cite 6 predicates, 2 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, cardiovascular panel, where it files most

How often FDA has decided Or-Nim Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Or-Nim Medical, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Or-Nim Medical, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?