BEUDAMED
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    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

    FDA Recall
    Terminated ·Diagnostic Hybrids Inc·Product code JZH·October 16, 2014

    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

    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

    Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett·Product code JDH·December 9, 2004

    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