BEUDAMED
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    Mx-Grafter

    FDA UDI
    MAXILON LABORATORIES INC·00860002195001·The Mx-Grafter Bone Grafting System is a manual...

    ebner 500 Series Blade

    FDA UDI
    MAXILON LABORATORIES INC·00860002195025·The ebner 502 expanded bone grafter is intended...

    ebner 502 Handle 30 degree Up Head Angle

    FDA UDI
    MAXILON LABORATORIES INC·00860002195049·The ebner 502 expanded bone grafter is intended...

    ebner 502 Handle Straight Head

    FDA UDI
    MAXILON LABORATORIES INC·00860002195032·The ebner 502 expanded bone grafter is intended...

    Mx-Grafter

    FDA UDI
    MAXILON LABORATORIES INC·20860002195005·The Mx-Grafter Bone Grafting System is a manual...

    ebner 502 Handle 30 degree Down Head Angle

    FDA UDI
    MAXILON LABORATORIES INC·00860002195056·The ebner 502 expanded bone grafter is intended...

    IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***

    FDA Recall
    Terminated ·Humagen Fertility Diagnostics, Inc.·Product code MQK·May 8, 2007

    Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** Used for the identification of Shigella species by the slide agglutination test

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code GNB·November 30, 2007

    VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEH·October 12, 2005

    Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·March 20, 2014

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006

    Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code KQC·July 27, 2018

    VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIH·February 1, 2017