SPARTRONICS STRONGSVILLE, INC.

FDA Device Registration & Listing · Strongsville, OH, US · Registration 3003144120

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
3003144120
FEI Number
3004099094
Entity Name
SPARTRONICS STRONGSVILLE, INC.
City/State/Country
Strongsville, OH, US
Establishment Address
22740 Lunn Rd, Strongsville, OH 44149, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Spartronics Strongsville Inc. (Owner Number: 9008727)
Owner / Operator Contact Address
22740 Lunn Road, --, Strongsville, OH 44149, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

D-Tect MT Accessory LipiView CardioInsight Cardiac Mapping System Riptide Aspiration System NeuroStar Advanced Therapy System NeuroStar Headrest NeuroStar Head Support System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2022-09-07
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2016-11-29
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-12-03
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2017-08-15
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2017-08-15
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2024-05-01
NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration Immunology Class 2 866.6020 2015-03-20
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2018-12-20
NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration Immunology Class 2 866.6020 2015-03-20
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2007-11-30
FRN Pump, Infusion General Hospital Class 2 880.5725 2007-11-30
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-12-03
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2014-09-18
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-08-22
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2025-08-22
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Neurology Class 2 882.5802 2025-03-17
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2025-03-17
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2025-07-03
ORZ Eyelid Thermal Pulsation System Ophthalmic Class 2 886.5200 2017-08-15
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2008-12-09
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2018-12-14

Official Correspondent

Casey Cramer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spartronics Strongsville 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
K243700 Mag & More GmbH Apollo TMS Therapy System 2025-09-04
K231926 Neuronetics, Inc. NeuroStar Advanced Therapy System (All previously cleared models) 2024-03-22
K935043 Siemens Medical Electronics SIEMENS CLINICAL WORK STATION 1995-04-07
K170948 Acutus Medical, Inc. AcQMap High Resolution Imaging and Mapping System 2017-10-16
K242016 ABBOTT MEDICAL EnSite™ X EP System 2024-08-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2016 Biosense Webster, Inc. 2
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003144120. Last updated year: 2026. Please use registration number 3003144120 when referencing this establishment in official correspondence.
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