Megadyne Medical Products, Inc
Cincinnati, OH, US
MEGADYNE MEDICAL PRODUCTS, INC. appears in FDA device records in Cincinnati, OH. FDA records list 50 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 31 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 50 510(k) clearances for Megadyne Medical Products, Inc between 1990 and 2024. The busiest year on record is 1991, with 17. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 17 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 3 |
| 1997 | 3 |
| 1998 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K213696 | ETHICON Megadyne Electrosurgical Generator | GEI | Substantially Equivalent | |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | FYD | Substantially Equivalent | |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | GEI | Substantially Equivalent | |
| K191328 | Megadyne Foot Switch | FYD | Substantially Equivalent | |
| K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER | GEI | Substantially Equivalent | |
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | |
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | |
| K072559 | SUCTION COAGULATOR | GEI | Substantially Equivalent | |
| K050579 | MEGA POWER ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | |
| K050102 | E-Z PEN, REUSEABLE HANDSWITCHING PENCIL | GEI | Substantially Equivalent | |
| K040699 | LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) | GEI | Substantially Equivalent | |
| K031285 | MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD | GEI | Substantially Equivalent | |
| K021077 | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD | GEI | Substantially Equivalent | |
| K982826 | MEGA 2000 | GEI | Substantially Equivalent | |
| K973346 | UNCOATED ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | |
| K972273 | TBD | GEI | Substantially Equivalent | |
| K965054 | PENCIL | GEI | Substantially Equivalent | |
| K953479 | BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K946237 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES | GEI | Substantially Equivalent | |
| K951035 | BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K943055 | ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES | GEI | Substantially Equivalent | |
| K945898 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES | GEI | Substantially Equivalent | |
| K942306 | IRRIGATION/ASPIRATION INSTRUMENT | GCJ | Substantially Equivalent | |
| K942489 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE | GEI | Substantially Equivalent | |
| K925478 | ELECTROSURGICAL ELECTRODE | HGI | Substantially Equivalent | |
| K933085 | GOODMAN BANDAGE | KGY | Substantially Equivalent | |
| K932102 | ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | |
| K926306 | FOOT CONTROL PENCIL | GEI | Substantially Equivalent | |
| K922002 | SUCTION IRRIGATION CAUTERY PROBE | GEI | Substantially Equivalent | |
| K913141 | MEGA MYELOGRAM KIT | FMI | Substantially Equivalent | |
| K913473 | E-Z CLEAN ELECTRODE | GEI | Substantially Equivalent | |
| K912597 | ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | |
| K913281 | E-Z CLEAN LAPAROSCOPIC ELECTRODE | GEI | Substantially Equivalent | |
| K912337 | ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS | GEI | Substantially Equivalent | |
| K911586 | GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) | BYY | Substantially Equivalent | |
| K910963 | THOROCENTESIS KIT | JOL | Unknown | |
| K910089 | MEGA LUMBAR PUNCTURE KIT | FMJ | Unknown | |
| K905060 | ELECTRODE EXTENDER | JOS | Substantially Equivalent | |
| K910362 | TRACHEOSTOMY CARE KIT | JOH | Substantially Equivalent | |
| K910369 | INCISION AND DRAINAGE KIT | KDD | Substantially Equivalent | |
| K910366 | MEGA GENERAL PURPOSE INSTRUMENT KIT | KDD | Substantially Equivalent | |
| K910365 | WOUND CLOSURE KIT | LRO | Substantially Equivalent | |
| K910363 | MEGA DRESSING CHANGE KIT | MCY | Substantially Equivalent | |
| K910361 | SUTURE REMOVAL KIT | MCZ | Substantially Equivalent | |
| K910368 | MEGA LACERATION KIT | LRO | Substantially Equivalent | |
| K904808 | ELECTROSURGICAL PENCIL | GEI | Substantially Equivalent | |
| K903302 | ELECTRODE, ELECTROSURGERY | JOS | Substantially Equivalent | |
| K903006 | ELECTROSURGICAL BIPOLAR FORCEPS | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1721194 | 1721194 | MEGADYNE MEDICAL PRODUCTS, INC. | 4545 Creek Rd., Cincinnati, OH 45242 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYDApparatus, Exhaust, Surgical
- KGYBag, Intestine
- JOLCatheter And Tip, Suction
- HGIElectrocautery, Gynecologic (And Accessories)
- JOSElectrode, Electrosurgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- LROGeneral Surgery Tray
- KDDKit, Surgical Instrument, Disposable
- GCJLaparoscope, General & Plastic Surgery
- FMJManometer, Spinal-Fluid
- FMINeedle, Hypodermic, Single Lumen
- MCZSuture Removal Kit
- JOHTube Tracheostomy And Tube Cuff
- BYYTube, Aspirating, Flexible, Connecting
- FCZTube, Smoke Removal, Endoscopic
- MCYWound Dressing Kit
Recall records
Showing 25 of 31| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2250-2024 | Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No | 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. | Class I | Open, Classified | |
| Z-2249-2024 | Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No | 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. | Class I | Open, Classified | |
| Z-2248-2024 | 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 Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No | 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. | Class I | Open, Classified | |
| Z-1920-2024 | 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. | Class I | Open, Classified | |
| Z-0600-2024 | Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus | 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. | Class I | Open, Classified | |
| Z-0599-2024 | Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus | 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. | Class I | Open, Classified | |
| Z-0598-2024 | Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord | 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. | Class I | Open, Classified | |
| Z-0597-2024 | 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. | Class I | Open, Classified | |
| Z-2257-2023 | 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 Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile) | 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). | Class II | Open, Classified | |
| Z-2001-2023 | MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-2000-2023 | MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-1999-2023 | MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-1998-2023 | MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-1997-2023 | MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-1996-2023 | MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-1995-2023 | MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-1994-2023 | MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery | Firm has received reports of patient burns in surgical procedures where device was used. | Class I | Open, Classified | |
| Z-2792-2018 | 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. | Class II | Terminated | |
| Z-1151-2014 | 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 electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused. | 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. | Class II | Terminated | |
| Z-2097-2013 | 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 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. | 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. | Class II | Terminated | |
| Z-0486-2010 | 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 intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. | Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07. | Terminated | ||
| Z-0785-06 | Button Switch Electrosurgical Pencil with Holster | Surgical device packaging may be damaged and may compromise sterility. | Terminated | ||
| Z-0784-06 | Rocker Switch Electrosurgical Pencil with Holster | Surgical device packaging may be damaged and may compromise sterility. | Terminated | ||
| Z-0783-06 | Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster | Surgical device packaging may be damaged and may compromise sterility. | Terminated | ||
| Z-0782-06 | Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster | Surgical device packaging may be damaged and may compromise sterility. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain