MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM— 510(k) K070475

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K070475 for MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM, Substantially Equivalent on 2007-05-07. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2007-02-20
Decision date: 2007-05-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Calgary, Alberta, CA

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Adverse events under product code NEZ

product code NEZ

Death: 11
Injury: 218
Total: 229

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.