AMER. EDWARDS LAB DIAFLEX URETERAL DILA— 510(k) K842639

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K842639 for AMER. EDWARDS LAB DIAFLEX URETERAL DILA, Substantially Equivalent on 1984-10-02. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1984-07-09
Decision date: 1984-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

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.