MICROCAP PLUS/NPB-75— 510(k) K024300

Substantially Equivalent

Oridion Medical 1987 , Ltd.

FDA 510(k) clearance K024300 for MICROCAP PLUS/NPB-75, Substantially Equivalent on 2003-04-03. Applicant: Oridion Medical 1987 , Ltd..

Clearance details

Applicant: Oridion Medical 1987 , Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2002-12-24
Decision date: 2003-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Jerusalem, IL

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.