20 results
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67ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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.
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·March 19, 2014
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
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 10, 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.
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·June 12, 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
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 10, 2024
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·January 3, 2024
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·January 3, 2024
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·January 3, 2024
Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·January 3, 2024
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.
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·September 4, 2013
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018
MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 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)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
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
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 10, 2024