E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE— 510(k) K842121

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K842121 for E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE, Substantially Equivalent on 1984-10-01. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code LJE
Advisory panel: Unknown
Date received: 1984-05-29
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

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.