EVICEL APPLICATION DEVICE— 510(k) K070575

Substantially Equivalent

Omrix Biopharmaceuticals , Ltd.

FDA 510(k) clearance K070575 for EVICEL APPLICATION DEVICE, Substantially Equivalent on 2007-05-29. Applicant: Omrix Biopharmaceuticals , Ltd..

Clearance details

Applicant: Omrix Biopharmaceuticals , Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2007-02-28
Decision date: 2007-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat Gan, IL

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.