BEUDAMED
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    LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Product Usage: The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 11, 2015

    Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K8067, MEVATRON M 6300 (MX), MEVATRON M 6730, MEVATRON M 7140, MEVATRON M 7400, MEVATRON MDX, MEVATRON MD (MD, MDX), MEVATRON M 7445 (MXE), MEVATRON M 7400/7440 (MXE), MEVATRON M 6730/6740 (MXE), MEVATRON M 6700 (MX): the intended use of the MEVATRON , PRIMUS , ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·January 21, 2015

    Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Part No.: 5694302; Mevatron K 8067, Part No.: 5694401; Mevatron KD, Part No.: 8319857; Mevatron KDS, Part No.: 9401522; Mevatron KDS2, Part No.: 9411588; and Mevatron KDS2, Part No.: 9822693, Siemens Medical Solutions USA, Inc., Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 27, 2007

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 15, 2020

    LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Product Usage: The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 19, 2014

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·February 18, 2020

    MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 15, 2017

    Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license from the Procter & Gamble Company, Cincinnati, OH 45202. UPC code 3 28785 20610 4.

    FDA Recall
    Terminated ·Product code KFZ·April 15, 2003

    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code GKZ·August 27, 2015

    Mevatron KD2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 1, 2011

    Mevatron KD-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 1, 2011

    Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007

    Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007

    Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007

    MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940753, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

    MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 25, 2017

    BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code MVU·November 23, 2009