CEA Medical Manufacturing, Inc.

FDA Device Registration & Listing · Colorado Springs, CO, US · Registration 1721983

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
1721983
FEI Number
1000064530
Entity Name
CEA Medical Manufacturing, Inc.
City/State/Country
Colorado Springs, CO, US
Establishment Address
1755 Merchants Ct, Colorado Springs, CO 80916, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Nissha Medical Technologies (Owner Number: 9002200)
Owner / Operator Contact Address
400 Exchange Street, --, Buffalo, NY 14204, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RF Catheter Cable STRATA II VALVE Atakr to ECG Cable, conductors-sterile, shrouded pin CAIMAN STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING (Component ONLY) TransDiscal* Y-Connecting Cable CAIMAN lntellaTip MiFi™ Reference Cable Non-Sterile CARDIOBLATE TISSUE DISSECTOR CARDIOBLATE LP CABLE EGM CARDIOBLATE DISP ELEC ADPTR CARDIOBLATE BP CARDIOBLATE GEMINI ECG Cable Nitron Remote CARDIOBLATE GEMINI Exacta Pole Clamp Mammotome Keypad and MR Lockbox Exacta External Drainage and Monitoring System Kimberly-Clark Radiofrequency Cables MicroThermX Microwave Ablation System (MTX-180) COOLIEF* COOLED RADIOFREQUENCY CONNECTOR CABLE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2013-02-26
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2023-12-20
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2012-12-12
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2013-02-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-07
IKD Cable, Electrode Physical Medicine Class 2 890.1175 1992-07-07
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-12
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2024-09-24
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2021-04-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-12-04
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2021-05-12
GAD Retractor General, Plastic Surgery Class 1 878.4800 2017-09-11
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-12
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2012-12-12
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2015-06-11
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-12-07
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2012-12-12
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2021-07-27
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2020-09-23
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2012-12-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2012-12-18
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-01-07
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2022-01-05
HCA Catheter, Ventricular Neurology Class 2 882.4100 2022-01-05
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2014-03-18
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2012-12-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-04-16

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
1317188 Graphic Controls Acquisition Corp.dba Nissha Medical Technologies BUFFALO, NY, US
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
1519132 Nissha Medical Technologies (Ohio), Inc. Norwalk, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K881966 C.R. Bard, Inc. ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER 1988-10-04
K192037 ABBOTT MEDICAL Advisor VL Circular Mapping Catheter, Sensor Enabled 2019-09-17
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721983. Last updated year: 2026. Please use registration number 1721983 when referencing this establishment in official correspondence.
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