K081440

Substantially Equivalent

BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES

Applicant: Smiths Medical Asd, Inc.
Product code: JOH
Advisory panel: Anesthesiology
Date received: 2008-05-22
Decision date: 2008-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, OH, US

Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.