BEUDAMED
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    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 26, 2012

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    FDA Recall
    Terminated ·Haag-Streit USA Inc·Product code HPT·August 17, 2012

    MobileDiagnost wDR motorized portable diagnostic X-ray systems.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·August 6, 2014

    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code OAR·December 6, 2017

    NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.

    FDA Recall
    Terminated ·Nico Corp.·Product code GEI·April 30, 2021

    Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.

    FDA Recall
    Terminated ·Nico Corp.·Product code GEI·April 30, 2021

    Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

    H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code OWF·May 5, 2017

    Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code OPL·May 5, 2017

    AIA-360 Automated Immunoassay Analyzer, Product Code 019945

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHO·January 10, 2020

    SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

    HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

    Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

    Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code LKC·May 5, 2017

    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

    CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

    Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code GOD·May 5, 2017

    Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code LKC·May 5, 2017

    AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CGN·November 30, 2018