Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011421558

FEI Number

3011421558

Entity Name

FORT DEFIANCE INDUSTRIES LLC

City/State/Country

Loudon, TN, US

Establishment Address

2411 MAREMONT PKWY, Loudon, TN 37774, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FORT DEFIANCE INDUSTRIES (Owner Number: 10048347)

Owner / Operator Contact Address

2411 MAREMONT PKWY, Loudon, TN 37774, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

P2131 P2131 Automated Field Steam Sterilizer P2131 Sterilizer Automated Field Steam Sterilizer P2131 Steam Sterilizer P2131 Field Steam Sterilizer Quadriciser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2015-01-01
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2022-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FORT DEFIANCE INDUSTRIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

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8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL
3022516928	DENT4YOU AG	Heerbrugg Sankt Gallen, CH
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011421558. Last updated year: 2026. Please use registration number 3011421558 when referencing this establishment in official correspondence.