NORTA— 510(k) K935630

Substantially Equivalent

Beiersdorf, Inc.

FDA 510(k) clearance K935630 for NORTA, Substantially Equivalent on 1994-10-07. Applicant: Beiersdorf, Inc..

Clearance details

Applicant: Beiersdorf, Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-23
Decision date: 1994-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.