BEUDAMED
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    Filters FDA Enforcement × Status: Terminated × Clear all

    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·November 18, 2015

    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 5, 2017

    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 5, 2017

    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics LLC·October 23, 2013

    QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.

    FDA Enforcement
    Class II ·Terminated·Inova Diagnostics Incorporated·April 4, 2018

    Digital RID Plate Reader and Software Product Code: AD400

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·January 25, 2017

    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·October 26, 2016

    TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).

    FDA Enforcement
    Class III ·Terminated·Technidata S.A.·April 9, 2014

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    FDA Enforcement
    Class II ·Terminated·Rocket Medical Plc·December 4, 2019

    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 30, 2021

    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·April 24, 2013

    BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016

    Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·July 25, 2018

    Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·July 25, 2018

    SlingBar Standard. Designed to meet the needs for lifting humans.

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·June 12, 2013

    SlingBar 360. Designed to meet the needs for lifting humans.

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·June 12, 2013

    Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016

    BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016

    Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016

    Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016