MEGADYNE MEDICAL PRODUCTS, INC.

FDA Device Registration & Listing · Cincinnati, OH, US · Registration 1721194

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
1721194
FEI Number
1721194
Entity Name
MEGADYNE MEDICAL PRODUCTS, INC.
City/State/Country
Cincinnati, OH, US
Establishment Address
4545 Creek Rd., Cincinnati, OH 45242, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Megadyne Medical Products, Inc. (Owner Number: 1721194)
Owner / Operator Contact Address
4545 Creek Rd., Cincinnati, OH 45242, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K133726
PMA Number
N/A

All Registered Proprietary Names

Patient Return Electrode E-Z Clean Modified Electrodes Ethicon Megadyne Electrosurgical Generator Round Bipolar Footswitch Megadyne Filter Megadyne Connect Cable, 1m Megadyne RF Sensor Megadyne Connect Cable, 2.1m Megadyne Smoke Evacuator Megadyne Fluid Trap Reusable Footcontrol Cable Mega Soft Reusable Return Electrode Pediatric Mega Soft E-Z Clean Laparoscopic Electrodes Suction Coagulator Patient Return Electrode E-Z Pen Reusable Pencil Mega Power Electrosurgical Generator MegaTip E-Z Clean Electrodes All-In-One ACE Blade E-Z Clean Mega Soft Dual Cord Mega Soft Universal Indicator Shaft Stainless Steel Electrodes Mega Soft Universal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-05
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2023-12-05
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-03-27
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2020-06-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-08-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-03-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-01-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-07-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Megadyne Medical Products, 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
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
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

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-0037-05 N/A 2
NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721194. Last updated year: 2026. Please use registration number 1721194 when referencing this establishment in official correspondence.
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