Company ยท US
Fort Defiance Industries, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
3recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FLE | Sterilizer, Steam | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 7, 2025 | K243801 | FRONT-LINE Field Sterilizer (FL135) Fort Defiance Industries, LLC | FLE |
| Mar 2, 2022 | K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 Fort Defiance Industries, LLC | FLE |
| Dec 16, 2014 | K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER Fort Defiance Industries, Inc. | FLE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2026 | Fort Defiance Industries, LLC Fort Defiance Industries (FDI), Automated Field Steam Sterilizer
REF: P2131 Open, Classified |
FLE | K141009 |
| Aug 19, 2021 | Fort Defiance Industries, LLC P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 Open, Classified |
FLE | K141009 |
| May 24, 2018 | Fort Defiance Industries, LLC FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641
Product Usage:
The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for ste Terminated |
FLE | K141009 |