EMPRINT PROCEDURE PLANNING APPLICATION— 510(k) K142048

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K142048 for EMPRINT PROCEDURE PLANNING APPLICATION, Substantially Equivalent on 2014-09-17. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-07-28
Decision date: 2014-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.