Graphic Controls Acquisition Corp.dba Nissha Medical Technologies

FDA Device Registration & Listing · BUFFALO, NY, US · Registration 1317188

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
1317188
FEI Number
1317188
Entity Name
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
City/State/Country
BUFFALO, NY, US
Establishment Address
400 Exchange St, BUFFALO, NY 14204, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Nissha Medical Technologies (Owner Number: 9106359)
Owner / Operator Contact Address
400 EXCHANGE STREET, --, Buffalo, NY 14204, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NeuroPlus Philips Connector Heartsync Multifunction Disposable Single Use AED Defibirllator Pads HEART SYNC PEDIATRIC, MODEL PED-100 Heartsync Multifunction Disposable Single-Use AED Defibrillator Pads Graphic Controls Ultra Film 1410500 Adult Solid Gel Tape Electrode

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-12-19
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-02-13
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2021-02-22
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2023-11-22
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2018-01-18
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2022-02-17
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2021-02-22
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 2023-12-19
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2021-02-22
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2016-08-10
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2023-06-27
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2018-02-27
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-10-18
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2021-02-22
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nissha Medical Technologies
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008933393 Nissha Medical Technologies Limited Paignton Devon, GB
3006891611 CEA Global Dominicana d.b.a. Nissha Medical Technologies San Pedro de Macoris, DO
3023164 LEAD-LOK, INC. d.b.a Nissha Medical Technologies Sandpoint, ID, US
1721983 CEA Medical Manufacturing, Inc. Colorado Springs, CO, US
1519132 Nissha Medical Technologies (Ohio), Inc. Norwalk, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K172182 St. Jude Medical (Now Part of the Abbott Medical) QUANTIEN Measurement System 2017-08-18
K252013 ABBOTT MEDICAL EnSite™ X EP System 2025-09-25

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 1317188. Last updated year: 2026. Please use registration number 1317188 when referencing this establishment in official correspondence.
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