Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135— 510(k) K213457

Substantially Equivalent

Fort Defiance Industries, LLC

FDA 510(k) clearance K213457 for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135, Substantially Equivalent on 2022-03-02. Applicant: Fort Defiance Industries, LLC.

Clearance details

Applicant: Fort Defiance Industries, LLC
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2021-10-27
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Loudon, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.