BEUDAMED
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    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·February 15, 2017

    Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.

    FDA Recall
    Terminated ·Biokit U.S.A. Inc.·Product code LGC·April 14, 2010

    VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 27, 2013

    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

    FDA Enforcement
    Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

    VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JGP·June 12, 2013

    TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code IYE·February 22, 2008

    TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

    FDA Recall
    Terminated ·Accuray Incorporated·Product code MUJ·July 7, 2011