209 results
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32ms
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Sources: EU EUDAMED, US FDA
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·January 13, 2016
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 21, 2021
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·April 21, 2021
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·November 11, 2021
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·November 11, 2021
SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAK·January 29, 2026
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code PFJ·December 3, 2015
GYNECARE GYNEMESH PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·May 7, 2026
GYNECARE TVT OBTURATOR W LASR
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 2, 2024
TVT DEVICE W/BLUE MESH 3 PK
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 2, 2024
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 2, 2024
TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 2, 2024
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 11, 2024
TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 11, 2024
Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876
FDA Recall
Terminated
·Ethicon, Inc. US·Product code HET·September 28, 2009
THERMACHOICE
FDA Adverse Event
Malfunction
·GYNECARE INC.·Product code MKN·January 11, 2002
THERMACHOICE
FDA Adverse Event
Malfunction
·GYNECARE INC.·Product code MKN·January 11, 2002
THERMACHOICE
FDA Adverse Event
Malfunction
·GYNECARE INC.·Product code MKN·January 11, 2002
THERMACHOICE II
FDA Adverse Event
Malfunction
·GYNECARE, INC.·Product code MKN·August 1, 2003
THERMACHOICE
FDA Adverse Event
Injury
·GYNECARE, INC.·Product code MKN·September 5, 2003