17 results
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49ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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 Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·February 27, 2014
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.
FDA Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·October 13, 2009
Button Switch Electrosurgical Pencil with Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
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 Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·August 7, 2013
Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·May 15, 2018
Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·December 20, 2002
Rocker Switch Electrosurgical Pencil with E-Z Clean Tip
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
Rocker Switch Electrosurgical Pencil with Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·December 20, 2002
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