BEUDAMED
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    CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018

    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc·February 5, 2020

    Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code KFM·July 26, 2005

    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.

    FDA Recall
    Terminated ·Fresenius Kabi, LLC·Product code LKN·April 19, 2011

    Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012