IntriCon Corporation Grey Fox

FDA Device Registration & Listing · Arden Hills, MN, US · Registration 3014498598

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014498598
FEI Number
3014498598
Entity Name
IntriCon Corporation Grey Fox
City/State/Country
Arden Hills, MN, US
Establishment Address
1275 Grey Fox Road, Arden Hills, MN 55112, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
INTRICON CORPORATION (Owner Number: 9039676)
Owner / Operator Contact Address
1265 Grey Fox Road, --, Saint Paul, MN 55112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stealth AXiS™

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2020-05-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTRICON CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007939342 IntriCon Corporation VH Vadnais Heights, MN, US
2134850 INTRICON CORPORATION ARDEN HILLS, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0033-2026 Medtronic MiniMed, Inc. 3
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014498598. Last updated year: 2026. Please use registration number 3014498598 when referencing this establishment in official correspondence.
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