CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)— 510(k) K946041

Substantially Equivalent

Cardico, Inc.

FDA 510(k) clearance K946041 for CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.), Substantially Equivalent on 1995-06-16. Applicant: Cardico, Inc..

Clearance details

Applicant: Cardico, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1994-12-12
Decision date: 1995-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Downey, CA, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.