K894613

Substantially Equivalent

BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE

Applicant: Bivona Medical Technologies
Product code: JOH
Advisory panel: Anesthesiology
Date received: 1989-07-20
Decision date: 1989-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, 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.