BEUDAMED
    46 results · 20ms · Sources: EU EUDAMED, US FDA

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    Lorad M-IV Mammography System

    FDA Recall
    Terminated ·Lorad, A Division of Hologic·Product code IZH·January 14, 2004

    Lorad MIV Platinum Mammograpgy System

    FDA Recall
    Terminated ·Lorad, A Division of Hologic·Product code IZH·January 14, 2004

    Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.

    FDA Recall
    Terminated ·Beekley Corporation·Product code IZH·July 2, 2012

    Seneographe 2000D Digital Mammography X-Ray System

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZH·February 6, 2004

    Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IZH·November 16, 2005

    Seneographe DMR Mammography X-Ray System (all versions)

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZH·February 6, 2004

    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code IZH·May 13, 2014

    Seneographe 700T Mammography X-Ray Systems

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZH·February 6, 2004

    GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.

    FDA Recall
    Terminated ·GE Healthcare·Product code IZH·July 1, 2008

    MammoTest Breast Biopsy System.

    FDA Recall
    Terminated ·Fischer Imaging Corporation·Product code IZH·July 9, 2004

    Seneographe 500 Mammography X-Ray Systems (all versions)

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZH·February 6, 2004

    GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.

    FDA Recall
    Terminated ·GE Healthcare·Product code IZH·July 1, 2008

    Seneographe 600 Mammography X-Ray Systems (all versions)

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZH·February 6, 2004

    Seneographe 800T Mammography X-Ray Systems

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZH·February 6, 2004

    Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LXH·January 22, 2009

    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    FDA Enforcement
    Class III ·Terminated·Biocare Medical, LLC·June 3, 2015

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·May 6, 2015

    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018