BEUDAMED
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    ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.

    FDA Recall
    Terminated ·Zeus Scientific, Inc.·Product code MYM·August 12, 2019

    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Enforcement
    Class III ·Terminated·Oxford Immunotec·September 23, 2020

    Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Enforcement
    Class III ·Terminated·Oxford Immunotec·September 23, 2020

    Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Recall
    Terminated ·Oxford Immunotec·Product code OJN·July 16, 2020

    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Recall
    Terminated ·Oxford Immunotec·Product code OJN·July 16, 2020

    Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. BesCon (brand)

    FDA Recall
    Terminated ·My Cosmetics Inc·Product code LPL·November 13, 2002

    SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008. Used to pass suture through tissue.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code MDM·June 18, 2010

    Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.

    FDA Recall
    Terminated ·Stryker Spine·Product code MDM·May 13, 2010

    FlexTrayTM Endopath Bariatric Tray, Kit Code TBW70S.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC06.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·May 21, 2003

    Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples with integral knife, Product No. #TLC10, staple size: 3 mm x 3.85 mm.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·May 21, 2003

    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

    FDA Recall
    Terminated ·Cochlear Americas Inc.·Product code MCM·June 5, 2015

    AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.

    FDA Recall
    Terminated ·Advanced Bionics, LLC·Product code MCM·February 17, 2020

    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

    FDA Recall
    Terminated ·Advanced Bionics, LLC·Product code MCM·March 18, 2019

    Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

    FDA Recall
    Terminated ·Advanced Bionics, LLC·Product code MCM·February 6, 2019

    ENDOPATH 10 mm Babcocks with Ratchet Handles (product code 10BB).

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TDC09.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004