TRACHEOSTOMY KIT— 510(k) K925288

Unknown

Ajs Medical Co., Inc.

FDA 510(k) clearance K925288 for TRACHEOSTOMY KIT, Unknown on 1993-08-27. Applicant: Ajs Medical Co., Inc..

Clearance details

Applicant: Ajs Medical Co., Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1992-10-21
Decision date: 1993-08-27
Decision: Unknown
Clearance type: Traditional
Location: Clarksburg, WV, US

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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.