BEUDAMED
    45 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.

    FDA Enforcement
    Class II ·Terminated·Stanmore Implants Worldwide Ltd.·September 13, 2017

    ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·May 4, 2022

    ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·September 20, 2023

    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

    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

    GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    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

    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·December 24, 2014

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 2, 2014

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 12, 2017

    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