BEUDAMED
    32 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

    FDA Enforcement
    Class II ·Terminated·Clinical Innovations, LLC·February 4, 2015

    Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·June 7, 2017

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    FDA Enforcement
    Class II ·Terminated·Clinical Innovations, LLC·October 21, 2015

    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 27, 2016

    StemPro¿ MSC SFM CTS"

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·November 13, 2019

    ACL TOP 300 CTS, automated coagulation laboratory instrument.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·July 23, 2014

    ACL TOP CTS, automated coagulation laboratory instrument.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·July 23, 2014

    ACL TOP 500 CTS, automated coagulation laboratory instrument.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·July 23, 2014

    ACL TOP 700 CTS, automated coagulation laboratory instrument.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·July 23, 2014

    Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 20, 2013

    Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.

    FDA Enforcement
    Class II ·Terminated·Life Technologies, Corp.·August 1, 2018

    Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

    FDA Enforcement
    Class II ·Terminated·Cook Medical Llc·January 20, 2021

    ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·September 25, 2013

    ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·September 25, 2013

    ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·September 25, 2013

    Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·September 26, 2012

    Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·September 26, 2012

    Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·September 26, 2012