BEUDAMED
    27 results · 19ms · Sources: EU EUDAMED, US FDA

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    Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04

    FDA Recall
    Terminated ·Gi Supply·Product code LRO·January 28, 2016

    Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04

    FDA Enforcement
    Class II ·Terminated·Gi Supply·March 16, 2016

    Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Medivators, Inc.·April 29, 2020

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Medivators, Inc.·April 29, 2020

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Recall
    Terminated ·Medivators, Inc.·Product code FAJ·October 9, 2019

    Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Recall
    Terminated ·Medivators, Inc.·Product code FAJ·October 9, 2019

    FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.

    FDA Recall
    Terminated ·Cook Endoscopy·Product code KNS·October 30, 2008

    Optima CT 540

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    Optima CT 520

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    CT Goldseal Optima CT 600

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    Revolution CT 160 1.5D STD WAUK

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    Discovery MI Digital Ready

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    Discovery MI Digital Ready

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KPS·May 24, 2018

    Optima CT 520

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    Optima CT 540

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    CT Goldseal Optima CT 600

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    Revolution CT 160 1.5D STD WAUK

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018