545 results
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12ms
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Sources: EU EUDAMED, US FDA
Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.
FDA Recall
Terminated
·Advanced Medical Optics, Inc.·Product code HQC·April 2, 2008
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code GEH·September 22, 2020
Universal SlingBar 600 with Quick-release Hook Product Number: 3156086 Used in combination with all lifts from Liko, i.e. mobile lifts and overhead lifts Used in combination with all lifts from Liko, i.e. mobile lifts and overhead lifts
FDA Recall
Terminated
·Liko AB Alvik·Product code FSA·July 1, 2008
Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. 3.5 fl. oz. (103.5ml) can.-(Product Number: 0386-0010-05-)
FDA Recall
Terminated
·Gebauer Company·Product code MLY·April 17, 2007
GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
FDA Recall
Terminated
·W. L. Gore & Associates Inc.·Product code MIH·January 6, 2020
Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
FDA Recall
Terminated
·Galil Medical, Inc.·Product code GEH·July 20, 2012
Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation B, Catalogue Number: 8065751552 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation Tabletop, Catalogue Number: 8065751150 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation LXT, Catalogue Number: 8065751550 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation LX, Catalogue Number: 8065751551 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation LT, Catalogue Number: 8065751549 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation Vision System w/Laser, Catalogue Number: 8065751145 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Constellation Vision System, Model: Constellation Vision System w/o Laser, Catalogue Number: 8065751147 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
FDA Recall
Terminated
·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010
Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively , by the use of Galil Medical I-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
FDA Recall
Terminated
·Galil Medical, Inc.·Product code GEH·October 25, 2019
Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.
FDA Recall
Terminated
·Symbiosis Corp.·Product code DQX·August 22, 2002
Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
FDA Recall
Terminated
·Symbiosis Corp.·Product code DQX·August 22, 2002