Fort Defiance Industries, LLC

FDA Regulatory Profile

Fort Defiance Industries, LLC appears in FDA public data with 2 recalls, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0121-2022, Class II) was initiated on August 19, 2021. Its most recent 510(k) clearance was granted on March 7, 2025.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0121-2022Class IIP2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641August 19, 2021
Z-2411-2018Class IIFDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 ProducMay 24, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K243801FRONT-LINE Field Sterilizer (FL135)March 7, 2025
K213457Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE FielMarch 2, 2022
K141009FORT DEFIANCE AUTOMATED STEAM STERILIZERDecember 16, 2014