ARDIEM MEDICAL, INC.

FDA Device Registration & Listing · Indiana, PA, US · Registration 3013480096

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
3013480096
FEI Number
3013480096
Entity Name
ARDIEM MEDICAL, INC.
City/State/Country
Indiana, PA, US
Establishment Address
1380 Route 286 Hwy E, Indiana, PA 15701, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Ardiem Medical, inc. (Owner Number: 10093545)
Owner / Operator Contact Address
1380 Route 286 East, Indiana, PA 15701, Indiana, PA 15701, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-06-02

Official Correspondent

Scott Rietscha

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ardiem Medical, inc.
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
K833646 Edward Weck, Inc. PULSATRON NERVE LOCATOR/STIMULATOR 1984-02-10
K150005 Ndi Medical, LLC Checkpoint, Checkpoint Head & Neck 2015-02-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013480096. Last updated year: 2026. Please use registration number 3013480096 when referencing this establishment in official correspondence.
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