Medtronic, Inc.

FDA Device Registration & Listing · Tempe, AZ, US · Registration 3004185781

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
3004185781
FEI Number
3004185781
Entity Name
Medtronic, Inc.
City/State/Country
Tempe, AZ, US
Establishment Address
2343 W. Medtronic Way, Tempe, AZ 85281, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211304
PMA Number
N/A

All Registered Proprietary Names

LINQ Tool Kit LINQ II Insertable Cardiac Monitor LINQ II Insertable Cardiac Monitor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2020-07-08
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2021-06-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3012520654 MEDTRONIC, INC. Billerica, MA, US
3004594267 Medtronic Care Management Services Lafayette, CO, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K253516 ABBOTT MEDICAL Assert-IQ (DM5100) 2025-12-18

Similar Registrations

Registration Number Establishment Name Location
2182208 MEDTRONIC, INC. Mounds View, MN, US
3009380063 Medtronic Distribution Center Memphis, TN, US
9614453 Medtronic Europe Sarl TOLOCHENAZ Vaud, CH
3008973940 Medtronic Singapore Operations Pte Ltd Singapore Central Singapore, SG
9616693 Boston Scientific Limited CLONMEL Tipperary, IE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004185781. Last updated year: 2026. Please use registration number 3004185781 when referencing this establishment in official correspondence.
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