BEUDAMED
    34 results · 12ms · Sources: EU EUDAMED, US FDA

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    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EZN·November 3, 2005

    Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code EZN·January 22, 2003

    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code EZN·January 22, 2003

    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code GJS·March 6, 2013

    Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 1, 2017

    Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code OUG·December 27, 2016

    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NBW·March 6, 2013

    The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code GKA·April 22, 2010

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·September 3, 2013

    VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code GKA·April 14, 2010

    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·April 24, 2013