510(k) K100875— CEROX, MODEL 321OF

Substantially Equivalent

Or-Nim Medical , Ltd.

Clearance details

Applicant: Or-Nim Medical , Ltd.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2010-03-30
Decision date: 2011-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lod, IL

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.