Data / Medical devices / United States / Megadyne Medical Products, Inc.
Megadyne Medical Products, Inc.: FDA-registered device maker in Cincinnati, OH, United States, 26 510(k) clearances
Megadyne Medical Products, Inc. is registered with the FDA (registration 1721194) in Cincinnati, OH, United States. It lists 5 device types. The FDA files 26 510(k) clearances under its listings, the newest dated July 12, 2024. 11 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1721194
- Address
- 4545 Creek Rd., Cincinnati, OH, United States, 45242
- Owner or operator
- Megadyne Medical Products, Inc. (1721194)
- Roles
- Specification developer
- First device listed
- April 5, 2007
- Registered through
- 2026
- Brand names listed
- ACE Blade, All-In-One, E-Z Clean, E-Z Clean Electrodes, E-Z Clean Laparoscopic Electrodes, E-Z Clean Modified Electrodes, E-Z Pen Reusable Pencil, Ethicon Megadyne Electrosurgical Generator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Exhaust, Surgical | FYD | 2 | Specification developer | accessdata.fda.gov |
| Electrocautery, Gynecologic (And Accessories) | HGI | 2 | Specification developer | accessdata.fda.gov |
| Electrode, Electrosurgical | JOS | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 12, 2024 | K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| June 26, 2020 | K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | FYD | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| May 27, 2020 | K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector | GEI | Substantially Equivalent | Ethicon Endo-Surgery | accessdata.fda.gov |
| March 24, 2020 | K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| February 18, 2015 | K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| January 24, 2014 | K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| December 16, 2008 | K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| October 21, 2008 | K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| October 5, 2007 | K072559 | SUCTION COAGULATOR | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| August 31, 2007 | K071080 | ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| March 31, 2006 | K060255 | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| March 24, 2005 | K050579 | MEGA POWER ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| February 1, 2005 | K050102 | E-Z PEN, REUSEABLE HANDSWITCHING PENCIL | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| June 4, 2004 | K040699 | LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| May 19, 2003 | K031285 | MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| April 17, 2002 | K021077 | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| November 6, 1998 | K982826 | MEGA 2000 | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| November 7, 1997 | K973346 | UNCOATED ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| January 24, 1997 | K965054 | PENCIL | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| December 21, 1994 | K943055 | ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| December 13, 1994 | K945898 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| June 27, 1994 | K925478 | ELECTROSURGICAL ELECTRODE | HGI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| September 2, 1992 | K922002 | SUCTION IRRIGATION CAUTERY PROBE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| August 16, 1991 | K913281 | E-Z CLEAN LAPAROSCOPIC ELECTRODE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| October 2, 1990 | K903302 | ELECTRODE, ELECTROSURGERY | JOS | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| September 12, 1986 | K862221 | E-Z CLEAN | GEI | Substantially Equivalent | American Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 17, 2024 | 94837 | Class I | Ongoing | Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrod | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. | accessdata.fda.gov |
| May 8, 2024 | 94544 | Class I | Ongoing | MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use. | Reports of patient burns. | accessdata.fda.gov |
| December 8, 2023 | 93597 | Class I | Ongoing | Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. | accessdata.fda.gov |
| June 15, 2023 | 92456 | Class II | Ongoing | MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction | An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU). | accessdata.fda.gov |
| June 1, 2023 | 92409 | Class I | Ongoing | MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | accessdata.fda.gov |
| May 15, 2018 | 80327 | Class II | Terminated | MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 | If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient. | accessdata.fda.gov |
| February 27, 2014 | 67641 | Class II | Terminated | Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosu | Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected. | accessdata.fda.gov |
| August 7, 2013 | 65995 | Class II | Terminated | E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouc | Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation. | accessdata.fda.gov |
| October 13, 2009 | 53555 | Not yet classified | Terminated | E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is int | Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07. | accessdata.fda.gov |
| April 6, 2006 | 35124 | Not yet classified | Terminated | Rocker Switch Electrosurgical Pencil with E-Z Clean Tip | Surgical device packaging may be damaged and may compromise sterility. | accessdata.fda.gov |
| December 20, 2002 | 25265 | Not yet classified | Terminated | Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE | The metal substrate cautery tip may break during use. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Electrode, Electrosurgical
- All makers of Apparatus, Exhaust, Surgical
- All makers of Tube, Smoke Removal, Endoscopic
- All makers of Electrocautery, Gynecologic (And Accessories)
Updated July 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.