5,569 results
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41ms
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Sources: EU EUDAMED, US FDA
TYCO-AUTO SUTURE UNITED STATES SURGICAL
FDA Adverse Event
Injury
·COVIDIEN PLC.·Product code GDO·July 13, 2010
Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·February 15, 2019
Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·February 6, 2009
LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Rd., Shanghai 201114, P.R. China. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
PELVICOL 2CM X 7 CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·May 2, 2013
PELVICOL ACELLULAR COLLIGEN MARTRIX
FDA Adverse Event
Injury
·COVIDIEN, TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·May 3, 2013
UNKNOWN PERMACOL PRODUCT
FDA Adverse Event
Malfunction
·COVIDIEN, TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·July 9, 2014
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLYTISSUE SCIENCE LABORATORIES, PLC·Product code FTL·December 18, 2013
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
FDA Enforcement
Class II
·Terminated·Covidien, PLC·March 27, 2019
PERMACOL 20X30 1.5MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·June 3, 2014
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·November 16, 2012
UNKNOWN PELVICOL PRODUCT
FDA Adverse Event
Injury
·COVIDIEN FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·December 4, 2012
PELVICOL ACELLULAR COLLIGEN MATRIX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·December 10, 2012
PELVICOL ACELLULAR COLLIGEN MARTRIX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·March 18, 2013
PELVICOL ACELLULAR COLLIGEN MARTRIX 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·March 18, 2013